CRA Handbook PDF

CRA
CRA CERTIFICATION GUIDE
CERTIFICATION
HANDBOOK
Academy of Clinical Research Professionals | 500 Montgomery St., Suite 800 | Alexandria, VA 22314 | www.acrpnet.org
Academy of Clinical Research Professionals

99 Canal Center Plaza, Suite 200
Alexandria, VA 22314
www.acrpnet.org
CCRA Exam Application Checklist

Exam Dates
September 4 - 27, 2014
Application Accepted
May 1, 2014 June 13, 2014 - $450 (Early-Bird
rate*) June 14, 2014 August 14, 2014 - $525
*ACRP Members always receive the Early-Bird rate!
Applications must be received by August 14, 2014.
Prepare to Apply
Read the Certification Handbook for important application steps, eligibility requirements, exam
preparation, and Certification exam information for which you are responsible for understanding.
Determine your eligibility before you apply. Eligibility requirements are detailed in the Certification
Handbook.
Obtain the correct application (e.g., CRC, CRA, or PI).
Complete the Application

Apply using your full, legal name. The first and last name must match your government issued
identification. Middle names are not considered.
When completing the Statement of Experience section, list all positions for which the essential duties
were performed. Dates of employment must match those listed on your CV/rsum.
Include your CV/rsum.
Include a job description with dates of employment for each position listed in the "Statement of
Experience" section to support your eligibility.
Include a program certificate or transcript (for work experience substitution only).
Confirm all documentation is in English. If original documentation was translated into English, it must also
be submitted in the original language, with the certified translated document.
Complete all sections completely and accurately.
Sign "Authorization and Agreement" (and "Payment" if paying by credit card) sections.
Submit the Application

Please consider submitting the online application if making payment by credit card.
Submit the complete application (e.g., application, supporting documentation and full payment) together.
Incomplete submissions will result in a denial of eligibility.
Ensure your application will be received by the due date.
Submit your application via e-mail, fax, or traceable mail (see Payment section for details). Use one
delivery method only to avoid duplicate charges.
Receive e-mail confirming the date your payment is applied.
September 2014
Table of Contents
Certification Resources on the Web .......................................................................................................................4
Quick Reference Questions .....................................................................................................................................5
Welcome to the Certified Clinical Research Associate (CCRA ) Program .........................................................6

What is Certification? ................................................................................................................................ 6
Top 10 Reasons to be a CCRA .............................................................................................................. 6

About the Academy of Clinical Research Professionals .......................................................................... 7
What is Required for Certification? ........................................................................................................... 8
Eligibility for the CCRA Program ..........................................................................................................................9

Certification Eligibility Requirements ........................................................................................................ 9
CRA Essential Duties ............................................................................................................................... 9
*Clinical Research Education Programs................................................................................................. 10
Application for the CCRA Program .................................................................................................................... 12

Application Form ..................................................................................................................................... 12
Supporting Documents ........................................................................................................................... 13
Application and Exam Fees .................................................................................................................... 13
Submitting the Application ...................................................................................................................... 14
Receipt of Application ............................................................................................................................. 14
Transfer Application to Next Exam Window ........................................................................................... 15
Refunds and Cancellation of Application ................................................................................................ 15
Eligibility Review ................................................................................................................................................... 16
Confirmation of Eligibility and Testing Information ................................................................................. 16
Ineligibility Decision Appeals Process .................................................................................................... 16
Exam Scheduling ................................................................................................................................................... 18
Services for People with Disabilities ....................................................................................................... 18
Rescheduling or Canceling an Exam Appointment ................................................................................ 19
Emergencies ........................................................................................................................................... 20
Prepare to Take the Exam ..................................................................................................................................... 20
Written Exam .......................................................................................................................................... 20
Language ................................................................................................................................................ 20
What is Covered on the Exam? .............................................................................................................. 21
Detailed Content Outline (DCO) ............................................................................................................. 21
Study Texts ............................................................................................................................................. 25
Abbreviations List ................................................................................................................................... 26
ACRP Online Preparation Support ......................................................................................................... 27
Preparing for the CCRA Exam .............................................................................................................. 27
Steps to Preparing for the CCRA Exam ............................................................................................... 28

Further Study Tips .................................................................................................................................. 29
Test-Taking Strategies............................................................................................................................ 29
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Taking the Exam .................................................................................................................................................... 30

Identification ............................................................................................................................................ 30
Time ........................................................................................................................................................ 30
Test Center Guidelines ........................................................................................................................... 31
Prepare to bring the following to your appointment ................................................................................ 31
Resources available at the Test Center ................................................................................................. 31
Expect the Unexpected .......................................................................................................................... 31
Exam Security ......................................................................................................................................... 32
Exam Results .......................................................................................................................................... 32
Duplicate Certificates ............................................................................................................................................ 32
Exam Scores .......................................................................................................................................................... 33
Scaled Scores and Score-Reporting FAQs ............................................................................................ 33
How are Certification Exams Developed? .......................................................................................................... 34
Reliability Measurements ....................................................................................................................... 35
Maintenance of Certification ................................................................................................................................ 36
Maintenance Requirements .................................................................................................................... 36
Frequently Asked Questions (FAQs) ................................................................................................................... 37
Certification-Related Policies ............................................................................................................................... 39
Non-Discrimination Policy ....................................................................................................................... 39
Discipline and Complaints Policy ............................................................................................................ 39
Certification Mark Use ............................................................................................................................ 39
Revocation of Certification ...................................................................................................................... 39
Policy on Release of Certificant Information .......................................................................................... 40
Confidentiality ......................................................................................................................................... 40
Verification of Credentials ....................................................................................................................... 40
Policy on Continuing Competency and Maintenance for CCRAs .......................................................... 40
Application-Related Policies ................................................................................................................................ 41
Transfers ................................................................................................................................................. 41
No Testing Appointment Scheduled ....................................................................................................... 41
Exam Cancellations ................................................................................................................................ 42
No Shows ............................................................................................................................................... 42
Emergencies ........................................................................................................................................... 42
Refunds .................................................................................................................................................. 42
Re-Examination ...................................................................................................................................... 43
Eligibility-Related Policies .................................................................................................................................... 44
CCRA Eligibility Policy ............................................................................................................................ 44
Policy on Denial of Eligibility ................................................................................................................... 45
Policy on Appeal of Denial of Eligibility................................................................................................... 47
Appeal Process ....................................................................................................................................... 47
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Exam Appointments, Testing Experience and Exam Outcomes ...................................................................... 49

Policy and Procedure on Special Accommodations ............................................................................... 49
Testing Center Experience Issues.......................................................................................................... 53
Certification Resources on the Web

Find important links to forms, resources, references, and more
all in one place.
Access Certification Resources
September 2014
Quick Reference Questions

Question type determines who needs to be contacted. Please refer to chart for common examples:
Question or Concern
Contact Whom?
Exam Registration
Exam application received?
The Academy
Didnt receive notification of eligibility
The Academy
What is my Prometric testing ID

number?
How can I locate a test site?
Contact Information
certification@acrpnet.org
The Academy
Prometric website
Exam rescheduling more than 29

days prior to exam
www.prometric.com/ACRP
Prometric
Call 800.853.6769
Exam rescheduling 16 to 29 days

prior to exam
Prometric - $25 fee
OR
Exam rescheduling 5 to 15 days prior

to exam
Prometric - $50 fee
No rescheduling permitted less than 5 days prior to exam date
Exam Transfers/Cancellations
Both: Prometric first to cancel
appointment, then notify the
Academy via e-mail
(Use Exam Transfer Request
Form if transferring)
Exam transfers/cancellation
more than 29 days prior to exam
16 to 29 days prior to scheduled exam
Both: Prometric first to pay

$25 change fee, then notify the
Academy via e-mail
Prometric: 800.853.6769
AND
E-mail the Academy:
Both: Prometric first to pay

$50 change fee, then notify the
Academy via e-mail
No cancellations are permitted fewer than five (5) days prior to the scheduled exam.
No refunds permitted fewer than five (5) days prior to scheduled exam.
5 to 15 days prior to scheduled exam
Post Exam Questions

Change of contact information
The Academy
General Contact Information

Prometric Member Services
To report issues with your Prometric
experience
September 2014
Prometric
800.481.6525
Prometric
800.853.6769
The Academy
Certification Department
Phone: 703.254.8100
Welcome to the Certified Clinical Research Associate (CCRA)

Program
The Academy of Clinical Research Professionals (the Academy) would like to congratulate you on your decision
to pursue Certification in your chosen field of work. As a professional in clinical research, you deserve to be
recognized and appreciated for what you do, and like most professionals, you want to become better at it. You
look for opportunities for ongoing professional development and practical ways to evaluate your own work that will
help you develop as a professional. This is one reason the Academys CCRA credential was created.
What is Certification?
Certification is a voluntary process to recognize individuals for meeting professional standards set by an impartial
third party. The Academy Certification is the formal recognition of clinical research professionals who have met
eligibility requirements and demonstrated proficiency of specific knowledge and jobrelated skills by passing a
standardized exam.
Academy Certification programs are the only ones in clinical research accredited by the National Commission for
Certifying Agencies (NCCA), which sets independent standards for the development and operation of certification
programs. NCCA accreditation assures the validity and credibility of the process. For more information on the
NCCA, please visit www.credentialingexcellence.org.
Top 10 Reasons to be a CCRA

1. Establishes credibility. Academy Certification serves as an impartial, thirdparty endorsement of your
knowledge and experience against international standards in clinical research. It adds to your credibility as a
clinical researcher and sets you apart from other professionals.
2. Improves career opportunities and advancement. Academy Certification can give you an advantage when
being considered for a promotion or other career opportunities. It clearly identifies you as an employee who
has demonstrated proficiency of internationally-accepted clinical research principles, techniques, and
application of best practices onthejob.
3. Increases onthejob responsibilities. Academy Certification is a clear indicator of your willingness to invest
in your own professional development. Certified professionals are aware of the constantly changing
environment within their profession, and possess the desire to anticipate and respond to change.
4. Enhances skills and knowledge. Achieving Certification through the Academy requires training, studying,
and keeping uptodate with changes in the profession. Becoming certified showcases your individual mastery
by confirming proficiency in the field. Academy Certification also requires Maintenance of Certification every
two years, to ensure you stay informed and continue to develop as a clinical research professional.
5. Fosters earnings potential. Many clinical research professionals who have become Academy certificants
experience salary and wage increases and/or bonuses based on their Certification status. In addition,
Academy certificants are in high demand and aggressively recruited.
6. Demonstrates engagement. Earning Certification through the Academy shows your peers, supervisors, and
trial subjects your commitment to your chosen career and the clinical research profession at large, as well as
your ability to perform to set standards.
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7. Strengthens the professions image. The Academys Certification program seeks to grow, promote, and
develop certified professionals who can serve as role models for good clinical practice (GCP) in the clinical
research field.
8. Validates accomplishment. Academy Certification is a reflection of personal achievement because you have
validated your skill set, specific to the job role you perform, by meeting internationally recognized standards
set forth via International Conference on Harmonization (ICH) Guidelines.
9. Builds selfesteem. Certification through the Academy is a step toward defining yourself beyond a job
description or academic degree, while gaining a sense of personal satisfaction.
10. Enhances recognition. As an Academy certificant, you can expect increased acknowledgment from your
peers for taking that extra step in your professional career.
About the Academy of Clinical Research Professionals

Founded in 2006 as an affiliate of the Association of Clinical Research Professionals (ACRP), the Academy of
Clinical Research Professionals (the Academy) is the certifying body responsible for the governance and
administration of the only job rolespecific, accredited credentials available to clinical research professionals.
The Academys Board of Trustees, elected by current certificants in good standing, is responsible for awarding
the CCRA credential and for establishing eligibility criteria, examination content, passing scores, and
Maintenance of Certification requirements.
The Certified Clinical Research Associate (CCRA ) credential was first awarded in 1995. The program is open to
any eligible clinical research professional, regardless of membership affiliation. The program consists of an
assessment of an eligible candidates professional experience and mastery of job-specific clinical research
principles and techniques, as measured by a written examination and periodic demonstration of continued
competence through the Maintenance of Certification process.
The Academy adheres to the highest standards by benchmarking its practices against standards set for
certification programs. The National Commission for Certifying Agencies (NCCA) of the National Organization for
Competency Assurance (NOCA) has established criteria for certification agencies, and in 2010, the Academys
CCRC and CCRA programs received NCCA accreditation.

As of January 2014, TransCelerate Biopharma, Inc. now recognizes certification through the Certified Clinical
Research Coordinator (CCRC) and Certified Physician Investigator (CPI) programs of ACRPs affiliate, the
Academy of Clinical Research Professionals (the Academy), as evidence of Good Clinical Practice (GCP)
training.
This exciting development means that TransCelerates membership of pharmaceutical and biotechnology
companies with research and development (R&D) operations, including 17 major firms to date working together to
create efficiencies within the clinical trials process, will save time and resources by not requiring CCRCs and CPIs
involved in their trials to complete redundant GCP training for each and every new study team they joinRead
more
Certified Clinical Research Associate (CCRA) Program
September 2014
From Regional to International Standards
1995
CCRA
(North
America)
1997
CCRA
(Europe &
Africa)
2014
2010
Over 9,000
ICH-based
CRAs Have
Exams
Become
NCCA-Accredited
Certified
550 Test Sites
Added
Computer-Based
Testing
What is Required for Certification?

In order to achieve certification, all applicants must meet the Eligibility Requirements and pass the Written
Exam.
The applicant should determine his/her own eligibility before submitting an application to the program. Upon
submission of a complete application, an eligibility review is conducted by the Academy. The candidate is then
notified of the eligibility review outcome via e-mail. All eligible candidates must then schedule an appointment to
take the exam.
Candidates who meet the eligibility requirements and pass the exam will be certified as having met the Academy
standards for becoming a CCRA , as adopted by the Academy. Maintenance of Certification of ones Certification
is required every two (2) years for continuance of the designation.
September 2014
Meet Eligibility
Requirements
Apply
Eligibility
Review
Schedule
Exam
Prepare
Pass
Exam
Eligibility for the CCRA Program

A clinical research associate (CRA), regardless of job title, supervises, monitors, and supports the administration
and progress of a clinical trial on behalf of a sponsor. The sponsor, whose intent is the research of
pharmaceuticals, biologics, or devices, may employ these individuals either directly or indirectly via contract
research organizations (CROs), or as independent consultants or contractors.
Certification Eligibility Requirements

In order to be deemed Eligible to take the CCRA exam, applicants for the CCRA credential must be able to
provide evidence through a job description, detailed CV or other documentation that they:
Work independently of the investigative staff conducting the research at the site or institution. This
means they do not report to the PI or site manager and that they do not have the ability to change or
manipulate data, and;
Work on behalf of the sponsor. This means that they are contracted by the sponsor to perform an
independent monitoring function. The sponsor can be a pharmaceutical or device company, a granting
agency, a university department, a physician, etc., and;
Perform all of the CRA Essential Duties as detailed below for a required minimum number of hours.
Hours performing the CRA Essential Duties can include hours documented up to the date of the exam
and/or through previous employment. The required number of hours is dependent upon ones
educational background.
This employment experience required by the Academy for eligibility is consistent with the criteria used by other
specialty certification boards in nursing and in allied health. The Academy believes that recent experience in
clinical research is a major source of knowledge and skills, as well as gaining an understanding of how to apply
those. The content and practice of clinical research is largely learned by doing given the limited number of
educational programs and the clinical research professional develops specialized knowledge and skills through
practice.
CRA Essential Duties

As defined by the Academy, and determined through ACRPs 2010 Job Analysis Survey, clinical research
associates who are eligible for CRA Certification must document cumulative performance of each of the following
Essential Duties during the dates of employment listed on the application:
Verify that the research site personnel, including the investigators, are conducting the study according to
the clinical protocol, Good Clinical Practices, and regulatory requirements;
Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC;
Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source
documents (source data verification);
September 2014
Review accuracy and completeness of site records (site study file, query resolution, and other data
collection tools);
Verify Investigational Product accountability;
Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial
management tracking system);
Conduct routine monitoring visits on behalf of the clinical trial sponsor.
CCRA Eligibility Requirements
At least one of the Eligibility Requirement options below should be met before applying for the CCRA program.
Education
Option 2
Registered Nurse (RN)
Associates degree
Other, such as LPN, LVN, Medical

Assistant, Lab Technician
Option 3
Required Documentation
of Performed
Essential Duties
3,000 hours*
Detailed CV/resume
and
Job Description
4,500 hours*
Detailed CV/Resume
and
Job Description
6,000 hours*
Detailed CV/Resume
and
Job Description
Bachelors degree (or higher)

or
Option 1
Minimum Hours
Performing
Essential Duties
or
High School diploma
*Clinical Research Education Programs

The Academy considers applicants who have completed a clinical research education program that meets the
following standards to have achieved a valid substitute for 1,500 hours of professional experience performing the
CRA Essential Duties.
Acceptable programs must:
Be at least 216 hours in length and;
Cover content that substantially maps to the topics found on the current CRA Detailed Content Outline
(DCO) and;
Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation

(CHEA). A list of recognized accrediting agencies can be found from the CHEA website:
www.chea.org/search.
September 2014
If an applicant submits an application using an educational program as a substitute for 1,500 hours of CRA work
experience, then the following information must be included on the applicants CV (see Appendix 1 for a sample
CV) and a certificate of completion must also be submitted:
Name of school
City and country in which the school is located
Program title
Name of organization that accredits the institution providing the program
Dates attended (From-To)
View Policy on Denial of Eligibility and Policy on Appeal of Denial of Eligibility.
September 2014
Meet
Eligibility
Requirements
Apply
Eligibility
Review
Schedule
Exam
Prepare
Take
Exam
Application for the CCRA Program

for September 4 27, 2014 Exam only
Application Dates
May 1 June 13, 2104 (Early-Bird)*
June 14 August 14, 2014 (Regular)*
*Received, not postmarked
Once an applicant has carefully determined he/she meets the eligibility requirements, the application process can
begin. A complete application has three (3) major components:
1. CRA Application Form
2. Supporting documentscurriculum vitae (CV)/resume and job description
3. Full payment
The Application Form, supporting documents, and full payment must be complete and submitted together by the
due date in order for the candidate to be considered for the next step (the eligibility review to take the written
exam).
Supporting
Documents
Application
Payment
Application
Ready to
Submit
Application Form
An online and printable Application Form is available on the ACRP website at www.acrpnet.org/cracertification.
Using the online application is recommended, as it is received immediately for eligibility review. Completed copies
are not available therefore, it is recommended for the applicant to take a screen shot if one is needed. Have all
documentation and employment information ready so that data in the online application is captured and does not
time out.
Applicants submitting a check or bank transfer must submit the printable version of the application. If completing
the printable application, make sure the application is received (not postmarked) by the Academy by the EarlyBird or Regular deadline.
September 2014
Have the following information ready before applying:
Work Experience
1. Employer(s) list only positions supporting experience performing the essential functions of a CRA.
2. Supervisor Name
3. Address
4. Phone
5. Supervisor Email
6. Start and End Date of Employment (consistent with CV/resume)
7. Average Hours Worked per Week (enter an exact number amount, i.e. 45)
The Academy has the right to verify qualifications. By submitting an application, applicants consent to and
authorize the Academy to verify the applicants academic and employment records. The Academy reserves the
right to request backup documentation to substantiate the reported information at any time during the
application process and/or once the candidate has been certified.
Supporting Documents
Supporting documentation is required for the education and work experience listed in the application. A detailed
CV or resume is required, which must include employers, corresponding employment dates, and a description of
the CRA essential duties performed by the applicant. Only positions in which the applicant has performed the
essential CRA job functions are considered, regardless of the job title. No other positions or study participation
listings will be considered.
Job Description
A job description is a required document that further details the tasks performed for each relevant position. It may
be employer- or applicant-created, and should list only the specific functions and tasks performed that support
ones eligibility.
Certificate/Transcript
Candidates who are substituting the completion of a clinical research education program for work experience are
required to provide a Certificate of Completion or transcript. (See Clinical Research Education Programs)
Application and Exam Fees

The cost to apply includes an Exam and Application fee. Early- Bird pricing applies for anyone applying early
and always applies for ACRP Members throughout the application period. The fees are as follows:
Application Fee
(non-refundable)
Exam Fee
(refundable)
TOTAL Due
September 2014
Apply Early
May 1 June 13, 2014
(Early - Bird)*
Apply
June 14 August 14, 2014
$125
$200
$325
$325
$450
$525
*ACRP/ APCR Members always pay the Early-Bird rate. Before you apply, log on to www.acrpnet.org to verify
your ACRP or APCR Membership status and confirm the total payment due at time of application.
The $325 Exam fee is refundable should an applicant not be eligible to take the exam or need to cancel within a
reasonable time frame. The application fee is non-refundable regardless of eligibility status or cancellation.
Credit card, check, or bank transfers are acceptable forms of payment.
Submitting the Application

CCRA Methods of Payment and Delivery
Payment Method
Application
Method
Online
Application
(recommended)
Credit Card
Documents Required to be Submitted WITH Application

1. CV/resume
2. Job description
3. Educational program certificate (if required)
Upload documents as part of application
1. CV/resume
2. Job description
Mail documents with application
1. CV/resume
Printable
2. Job description
Check or
Application
Bank/Wire Transfer
(only via Mail)
Mail documents with application
Only applications received with required supporting documentation and full payment will be processed. Note: File
sizes must be less than five (5) megabytes for online applications.
Printable
Application
(Mailed or Faxed))
VERY IMPORTANT: Incomplete applications, or applications submitted without the correct fee, will not be
processed. It is the candidates responsibility to submit all relevant documents at the time of application. All fees
must be paid in full by check or credit card (American Express, Visa, or MasterCard). Corporate checks must
reference each applicants name.
Submission of the application constitutes agreement that the candidate has read, understood, and agrees to
abide by the ACRP/APCR Code of Ethics and Professional Conduct. Applicants are required to sign a
disclosure statement attesting to the accuracy of the information provided as part of the application process. By
submitting an application, the applicant consents to and authorizes the Academy to verify the candidates
academic and employment records.
Application for, and achievement of, Academy Certification is between the Academy and an individual candidate.
Therefore, application details and status, fees, eligibility status, exam appointments, and exam results are
confidential to the individual and cannot be disclosed, regardless of payer. Only the candidate is permitted to
withdraw an application or cancel an exam appointment, regardless of payer.
Receipt of Application
An e-mail confirmation of payment is automatically sent once payment is processed. At that point, your application
will enter the Eligibility Review process. Please allow up to 10 days to receive notification regarding an eligibility
decision.
September 2014
To ensure you receive important Certification-related notifications, add www.acrpnet.org to your safe senders list
(contact your IT department for instructions).Please take any necessary steps to prevent filtering of ACRP emails.
If the printable application is submitted, it is highly recommended that the applicant mail it to the Academy via
certified mail, express parcel service, or another traceable courier to ensure receipt by the application receipt
deadline. Keep fax confirmations for tracking purposes, if sending the application via fax.
Transfer Application to Next Exam Window

The Academy offers a one-time transfer from the current exam offering to the next. There are two situations in
which candidates may take advantage of this:
1. If a candidate is determined ineligible for the current exam window, but will have met the eligibility
requirements by the next exam window; or
2. If an eligible candidate withdraws from taking the original exam for any reason (up to five [5] days before
a scheduled exam appointment)
Transfers are applied toward the next exam only. Transfer of eligibility and associated fees will be applied only to
the original candidate and are not transferable to another person, even if paid for by a third party. Exam fees are
transferred toward the next exam only and not toward other products or services.
If you choose to transfer to the next exam window for one of the two reasons above, you must submit a Request
to Transfer Exam Application Form before the end of the exam window for which the you had originally applied.
If you have an exam appointment scheduled, you must first cancel it directly with Prometric (see chart, section
Rescheduling or Canceling an Exam Appointment ) before submitting the Request to Transfer Exam
Application Form to ACRP. Fees, payable to Prometric directly, apply for appointment cancellations made within
thirty (30) to five (5) days prior to an appointment date. Cancellations are not permitted less than five (5) days
prior to an appointment.
If a transfer candidate does not submit the request before the end of the current exam testing window, then all
funds originally submitted will be forfeited. Transferring is not an option for re-examination candidates (from the
previous exam cycle).
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination
Refunds and Cancellation of Application

Once a candidate submits an application, it cannot be withdrawn. Candidates who wish to discontinue the
Certification process may submit an Application Cancellation Request Form to obtain a refund of the Exam
Fee only. The application fee is nonrefundable. If a candidate submits such a request after the candidate has
received an Eligibility ID, the ID number will be invalidated.
The only portion of the total amount submitted that will be refunded is the exam fee, provided that the request is
received at least five (5) calendar days prior to a scheduled exam appointment (if one is scheduled). Cancellation
requests received after that time will not be honored. Refunds are not available to candidates who do not
schedule or attend the exam.
Only the candidate may request a cancellation or refund, regardless of whether the exam fee was paid by the
candidate or another party. Employers supporting a candidates fees cannot request or receive a refund for fees
September 2014
paid to the Academy. Any refund will be sent to the party who initially paid for the exam. If payment was made by
credit card, that card will receive the credit. If the payment was made by check, the Academy will mail a refund
check to the original payer.
Applicants who do not meet the eligibility requirements for the exam (i.e., those who are ineligible), or who are
ineligible due to an incomplete application, will receive a refund of the exam fee only, within three weeks of the
final ineligibility notification.
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination.
Meet
Eligibility
Requirements
Apply
Eligibility
Review
Schedule
Exam
Prepare
Take
Exam
Eligibility Review
The Eligibility Review process includes verifying completeness of the application and determining whether or not
the applicant meets the eligibility criteria for the exam. Applicants should expect to receive an update via email
within seven to ten days after the application has been received.
It is not unusual for an applicant to receive a request for additional and/or clarifying information from an Eligibility
Reviewer. These requests will come via e-mail. Applicants will have seven (7) calendar days to respond to the
request. Applicants who do not respond to the request for additional or clarifying information will automatically
have their applications determined incomplete and therefore are ineligible to take the exam. Ineligible applicants
will be refunded the exam fee ONLY, and will need to re-apply to the program and pay all fees if they decide to
pursue Certification in the future. Incomplete applications will not be returned.
Confirmation of Eligibility and Testing Information

If an applicant is determined to be eligible after the application has been reviewed, the candidate will be e-mailed
an Eligibility Notice, with further instructions as to how to schedule his/her exam appointment. A candidate must
schedule an Exam Appointment or forfeit any fees paid. Exam Appointments cannot be scheduled before
eligibility is determined.
If an applicant is determined to be ineligible during initial review, the application is automatically reviewed by a
second reviewer. If the second reviewer also determines the applicant to be ineligible, the application is
automatically sent to the Director of Certification for a third review. Applicants are notified via e-mail at each step
of the review with an explanation of the deficiency identified.
If, after the three levels of review, the applicant is still determined to be ineligible, the applicant can choose to
appeal to the Academy Board of Trustees. However, after the third level of review by the Director of Certification,
applicants can no longer submit new documents to overturn an eligibility decision.
Applicants found to be ineligible who do not initiate the Appeals process within the stipulated timeframe will
automatically be refunded the exam fee only, within two (2) weeks.
Ineligibility Decision Appeals Process
September 2014
The Academy of Clinical Research Professionals (the Academy) makes every attempt to make fair and accurate
eligibility decisions based on the information provided by the applicants. An appeal procedure is available to any
applicant who has applied for certification by the Academy and who wishes to contest any adverse decision
affecting his or her application for certification status. Any individual who does not file a request for an appeal
within the required time limit shall waive the right to appeal.
Candidates are permitted to appeal a decision made during the review of his/her application for certification.
Candidates are not permitted to appeal:
1. The passing score for the exam, or the process used to establish that passing score, which may result in
failure of the certification examination.
2. Existence of an eligibility requirement. The Policy on the Appeal of Denial of Eligibility provides for
appeal of the interpretation of the eligibility requirements in individual applicants circumstances.
Candidates do have the ability to appeal the content and quality of the examination, as well as questions and
answers. However, candidates may not have access to the test form, their answers, or the answer key. Read the
Academys Policy on Appeal of Denial of Eligibility section, for details.
September 2014
Meet Eligibility
Requirements
Apply
Eligibility
Review
Schedule
Exam
Prepare
Take
Exam
Exam Scheduling
Exam Dates
September 4 - 27, 2014
The Academy offers a 24-day testing window. All candidates who have been determined eligible must schedule
an appointment to take the exam.
Exams are scheduled through Prometric, the Academys testing partner, and may be taken at approximately 600
testing centers internationally. Only candidates determined to be eligible will receive an Eligibility Notice
immediately following the Eligibility Review process. This important notice includes a Prometric ID number, the
Prometric web address, and instructions for scheduling an exam appointment. The candidate must also verify that
the FIRST and LAST name on the Eligiblity Notice (registered with Prometric and ACRP) is identical to the first
and last names displayed on the candidates's current, government-issued identification (ID). The ID must also
bear a photo and signature to be an acceptable form of ID. See Taking the Exam section.
Only when the name matches the candidates legal identification, should the candidate schedule an exam
appointment. The testing center, exam date, and time are available on a first-come, first-served basis.
To view testing locations, visit www.prometric.com/acrp at any time. For detailed assistance with selecting your
test center, view www.acrpnet.org/PDF/ExamSites.pdf.
Services for People with Disabilities

The Academy is committed to ensuring that no individual with a disability is deprived of the opportunity to take an
exam solely by reason of that disability. The Academy will provide reasonable accommodations for candidates
with disabilities pursuant to the Americans with Disabilities Act (ADA). The following reasonable accommodations
may be addressed:
Wheelchair access is available at all established test centers.
Candidates with visual, sensory, cognitive, or physical disabilities that would prevent them from taking an
exam under standard conditions may request reasonable accommodations and arrangements.
To request a reasonable accommodation, one is required to:
Submit to the Academy a Special Accommodations Form, signed by a licensed health professional
approving the request as accurate and reasonable.
Check the designated box on the exam application.
A link to the Special Accommodations Form is available on the website and also in the online and printable
applications. Submit this form with your application to certification@acrpnet.org. Only reasonable
accommodation will be made during the available exam window.
September 2014
Rescheduling or Canceling an Exam Appointment

Rescheduling or canceling an exam appointment (test center location, date, or time) is permitted by Prometric up
to five (5) days before your scheduled appointment. There may be fees associated with appointment
changes, as noted in the chart below. Rescheduling availability varies, depending on the test center location, and
number of days prior to the exam appointment date.
To reschedule or cancel an exam appointment, you must contact Prometric directly at 800.853.6769.
If you do not plan to take the exam during the current exam window, you must submit one of the following
requests AFTER you have cancelled your exam appointment:
1. Application Cancellation Request ( for cancellation and requesting a refund only); submit up to 5 days
before scheduled appointment. Refer to the Refunds section.
OR
2. Request to Transfer Exam Application Form (for transferring your application to the next exam
window only) ; submit by last possible exam date. Refer to the Transfer to Next Exam Window section.
Your request must be received by the Academy at certification@acrpnet.org within the time specified or all fees
paid will be forfeited.
Exam Appointment Rescheduling / Cancellation

Contact Prometric directly at 800.853.6769 or online at www.prometric.com/ACRP.
Time Before Appointment

More than 30 days before
scheduled appointment
Prometric Fees
No charge
29 to 16 days before scheduled

appointment
$25
15 to 5 days before scheduled

appointment
$50
Less than 5 days before

scheduled appointment
Method
Online or via phone
Online or via phone
Online or via phone
Not permitted All fees forfeited
Cancellations due to emergency
See policy below
Failure to appear for scheduled

exam
All fees forfeited
Emergency Exam Cancellation

Form sent to the Academy
View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination.
September 2014
Emergencies
If a candidate will be unable to keep his/her exam appointment due to an emergency situation that arises within
five (5) days prior to his/her exam date, the candidate is required to submit an Emergency Cancellation Form
and official documentation to the Academy at certification@acrpnet.org. This information must be received up
to seven (7) calendar days after the candidates scheduled exam date. The following situations will be considered
with documentation:
Emergency room visit or hospitalization

Severe medical condition requiring hospitalization
Death of an immediate family member (e.g., spouse, child/dependent, parent, grandparent, sibling)
Call to active military duty
Jury duty
Meet
Eligibility
Requirements
Apply
Schedule
Exam
Eligibility
Review
Prepare
Take
Exam
Prepare to Take the Exam
Preparation to take the Certified Clinical Research Associate (CCRA ) examination can begin as early as one
decides to pursue Certification. Understanding the exam content, as well as how to apply ones knowledge and
experience while taking the exam, is essential to successfully becoming certified.
Written Exam
The CCRA examination is designed as a practice-based exam for individuals involved in the performance of the
essential duties of a clinical research associate to assess proficiency of the five (5) core knowledge areas:
1.
2.
3.
4.
5.
Investigational Product Management

Protocol
Safety
Trial Management
Trial Oversight
The examination consists of 125 multiple-choice questions (25 of these questions are pre-test items and do not
affect a candidates score). Candidates are presented with a question and are asked to choose the single best
answer from the four options provided. Only one answer is correct. The questions test recall, application, and
analysis. Some questions use hypothetical scenarios. The exam content is based on a process of expert peer
review, performed by the Global CCRA Exam Committee. There are no trick questions on the exam, and there
is no penalty for guessing.
Each candidate is allowed a maximum of three (3) hours to complete the exam.
Language
September 2014
The CCRA exam is provided in English.

Exam candidates may bring a hard-copy (Electronic dictionaries are not permitted) EnglishGerman/Spanish/Chinese/Hindi/etc. translation only dictionary to the exam. Dictionaries containing any word
definitions or other extraneous markings are strictly prohibited. The dictionary will be inspected by the proctor
prior to and after the exam is completed. Any attempt to compromise the exam will be grounds for immediate
dismissal from the site, invalidation of the exam score, and possible legal action. No additional time is given to
those using a translation dictionary.
What is Covered on the Exam?

The Detailed Content Outline
To be certified, clinical research associates are expected to have general knowledge of:
laboratory terminology, tests, and procedures
basic math, including adding, subtracting, multiplying, dividing, and calculating percentages
To be certified, clinical research associates are expected to have proficiency in the areas of:
The Detailed Content Outline (DCO) for the Clinical Research Associate Exam.
Detailed Content Outline (DCO)

The DCO is derived from the 2010 ACRP Job Analysis Survey, a careful description of the tasks performed by
clinical research associates. Nearly 4,000 clinical research professionals participated in the 2010 survey. This
survey is conducted every five (5) years. The DCO is updated accordingly and the exam questions revised to
reflect any changes in practice. Each question on the exam is based on this outline. Therefore, to prepare to take
the exam, one should study this outline and especially consider the underlying knowledge, skills, and abilities
needed to perform as a clinical research associate.
Certified Clinical Research Associates (CCRAs) shall have proficiency in:
I.
Investigational Product Management
Develop and update the instructions for use of investigational product

Initiate shipment of investigational product to site
Ensure adequacy of investigational product and other supplies at site
Ensure randomization and emergency codes of investigational product have been maintained
Ensure proper storage, dispensing, handling, and disposition of investigational product and other
supplies
Reconcile investigational product and other supplies
Maintain accountability of investigational product
Retrieve investigational product and calculate subject compliance
Maintain randomization and emergency codes of investigational product dispensing
Using knowledge of:
September 2014
Investigational product (e.g., package insert, report of prior investigations, Investigator's

Brochure)
Investigational product inventory
Investigational product accountability
Investigational product storage
Packaging and labeling
II.
Product development
Supplemental/ rescue/ comparator product
Investigational product compliance (e.g., protocol, standard operation procedures, local
governance)
Accountability records
Protocol
Review product development plan

Identify study objective/design
Develop the protocol (e.g., inclusion/exclusion criteria, procedures, schedule of events, safety
and efficacy parameters)
Evaluate protocol for scientific soundness
Evaluate protocol for feasibility
Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data
capture (EDC) with the study protocol
Verify the eligibility of potential trial subjects
Contribute to protocol development
Coordinate protocol approval process
Review protocol for feasibility
Review protocol during investigators meeting
Execute study per protocol
Recommend and Implement protocol amendments
Using knowledge of:
III.
Protocol development
Protocol submission and approval procedures
Clinical trial phase
Study design characteristics (e.g., double-blind, crossover, randomized)
Study objective
Description of procedures
Amendment submission and approval procedures
Inclusion/exclusion criteria
Statistical plan
Safety
Assess safety during trial participation

Minimize potential risks to subject safety
Oversee safety risks (e.g., clinical holds, product recalls)
Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected,
unexpected)
Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts)
Conduct study-related procedures and monitor the safety of the trial subjects and investigational
staff
Manage and motivate the investigational staff and other disciplines involved, and take measures
to minimize any potential risks
Review common laboratory values and alerts
Identify expected or unexpected results associated with investigational products
Maintain follow-up to determine resolution of adverse event
Conduct safety monitoring/reporting activities
September 2014
Using knowledge of:
IV.
Investigators Brochure
Safety monitoring
Safety and clinical databases
Subject safety issues (e.g., toxicity, significant lab values)
Vulnerable subject populations
Adverse events reporting
Serious adverse events reporting
Safety reporting requirement
Trial Management
Verify investigator/site feasibility

Develop timelines for conducting and completing the clinical trial
Prepare and conduct initiation activities
Ensure appropriate training of the investigational staff
Develop a recruitment strategy and study management plan
Follow a recruitment strategy and study management plan
Review, clarify, and obtain data changes from sites
Schedule and coordinate pre-study site visit
Identify minimum regulatory document requirements for site trial master file (e.g., country-specific
regulatory documents)
Ensure IRB/IEC review/approval of study and study documents
Facilitate site budget/contract approval process
Develop Case Report Forms (e.g., CRFs, eCRFs)
Develop CRF completion guidelines
Develop monitoring guidelines/plans
Develop project tools
Submit documents to regulatory authorities
Document and communicate site visit findings
Ensure clinical trial registry requirements are met
Ensure timely review of study data (e.g., laboratory results, x-rays)
Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
Prepare and conduct interim monitoring visit(s)
Prepare and conduct close-out monitoring visit(s)
Reconcile payments to sites per contract
Document protocol deviations/violations
Reconcile safety and clinical databases
Conduct co-monitoring/training visits
Perform remote monitoring activities
Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g.,
protocol procedures, EDC)
Transmit CRFs to data management
Review CRF queries from data management
Coordinate study monitoring visits
Draft study specific tools (e.g., source document, tracking tools)
Implement corrective actions plans
Maintain trial master file (e.g., regulatory binder)
Manage study supplies (e.g., lab kits, case report forms)
Comply with subject privacy regulations
Manage study issues
September 2014
Using knowledge of:

Site Activities
Contract budget negotiations and approval process
Project feasibility
Project timelines
Monitoring guidelines/plan and tools
Study project tools
Staff qualifications
Staff roles and responsibilities
ata management activities
Plan for staff oversight
Investigator qualifications/ site selection (e.g., therapeutic area, education, experience)
Disposition of unused study-related materials (e.g., CRF at end of study, destruction of lab kits)
Equipment and supplies (e.g., x-ray, computer, lab kits) and storage
Study management plan (e.g., timelines, data management)
Communication documentation (e.g., telephone, email)
Pre-study site visit
Investigator's meeting
Site initiation
Monitoring visit
Close-out visit
Site monitoring visit log
Site signature log
Delegation listing
Trial master file (e.g., site, sponsor)
Data management plan
Data query resolution
Electronic data (e.g., electronic health records, electronic case report forms)
Recruitment plans/strategies
Subject compliance
Subject visit logistics
Protection of human subjects
Subject selection, screening, and recruitment
Subject retention
Subject discontinuation
Subject reimbursement
Good Clinical Practice (GCP)
Regulatory documents
Record retention
Subject privacy regulations
Case Report Form (CRF/eCRF)
Visit reports (e.g., initiation, close-out)
Final report
Progress reports
Essential documentation, subject related and non-subject related (e.g., past medical records, lab
reports, protocol, IRB approvals)
Informed consent
Procedure manuals
Source documentation
September 2014
V.
Protocol deviations
Indemnification/insurance
Clinical trial registry
Trial Oversight
Ensure consistency between the sites standard operation procedures (SOPs) and the study
requirements
Ensure investigator/site protocol compliance
Facilitate investigator/site corrective actions
Oversee vendors (e.g. Contract Research Organizations (CROs)
Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
Ensure adequate site management
Prepare the study site for audits and inspections
Respond to or facilitate response to audit/inspection findings
Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of
slides, freezing, refrigeration)
Ensure proper adverse event reporting by the investigator
Escalate problems to appropriate in-house management
Investigate potential fraud and misconduct
Report potential fraud and misconduct
Ensure follow-up medical care for study subjects is documented, as applicable
Ensure adequate consent and documentation
Ensure staff, facility, and equipment availability throughout the study
Ensure compliance with study requirements and regulations
Prepare for audits, inspections, and follow up
Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect
confidentiality by limiting unauthorized access
Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are
on file
Using knowledge of:
Issues management (e.g., escalation)

Audit preparation
Regulatory standards
Audit documents
Project monitoring guidelines
Project investigator supervision requirements
Study Texts
In order to prepare for the exam, all candidates should review and be familiar with the relevant regulations from:
ICH Guidelines (E2A, E6, E8, E9)

Declaration of Helsinki (latest version)
The most current copy of the ICH Guidelines and other regulatory materials may be found on the following
websites:
ICH Guidelines: www.ich.org (Go to Work Products ICH Guidelines Efficacy Guidelines)
Declaration of Helsinki: www.wma.net/en/20activities/10ethics/10helsinki/index.html
September 2014
Abbreviations List
Access to the Abbreviations List here is accessible on each screen during the exam. You can expect to see the
following terms abbreviated as shown.
Certification Exam Abbreviation List

ADR
Adverse Drug Reaction
AE
Adverse Event
ALT
Alanine transaminase
AST
Aspartate transaminase
b.i.d.
twice a day
BP
BUN
C
CIOMS
CK
blood pressure
Blood Urea Nitrogen
Celsius
Council for International Organizations of Medical Sciences
Creatine Kinase
CRA
Clinical Research Associate
CRC
Clinical Research Coordinator
CRF
Case Report Form
CRO
Contract Research Organization
CV
DCF
IDMC/DSMB
Curriculum Vitae
Data Clarification Form
Internal Data Monitoring Committee / Data and Safety Monitoring Board
ECG
Electrocardiogram
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
EKG
Electrocardiogram
FEV1
Forced Expiratory Volume in 1 Second
GCP
Good Clinical Practices
GI
Gastrointestinal
GLP
Good Laboratory Practices
GMP
Good Manufacturing Practices
hCG
Human Chorionic Gonadotrophin
HMO
Health Maintenance Organization
IB
September 2014
Investigator's Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IP
IRB/IEC
Investigational Product
Institutional Review Board/Independent Ethics Committee
LAR
Legally Acceptable Representative
MAO
Monoamine Oxidase
mcg
mircogram
mmHg
Millimeteres of mercury
NSAID
Non-Steroidal Anti-Inflammatory Drug
PI
Principal Investigator
PK
Pharmacokinetics
p.r.n.
as needed
QA
Quality Assurance
QC
Quality Control
q.d.
once a day
QTc
ECG / EKG QT interval corrected for heart rate
RBCs
Red Blood Cells
SAE
Serious Adverse Event
SMO
Site Management Organization
SOP
Standard Operating Procedure
SUSAR
t.i.d.
wBCs
Suspected Unexpected Serious Adverse Reaction

three times a day
White Blood Cells, or leukocytes
ACRP Online Preparation Support

Optional exam preparation support is available for purchase online, from the Certification Exam Preparation
webpage. There are options to purchase components separately or in a package. Visit the webpage for details
and pricing for each option:
Cert Exam Prep Self-Paced eLearning Course

Exam Review Preparation packages
Exam Practice Exercise- an Internet
Cert Exam Prep Classroom Course
Preparing for the CCRA Exam
The CCRA examination is intended to assess your proficiency of the body of knowledge required to perform in
your job role as a clinical research associate. The knowledge and tasks that are being tested are based on
current practice in clinical research. It is testing your knowledge of ICH and GCP and the application of those
guidelines in the conduct of your job duties and responsibilities. It is not testing how your employer or you
personally carry out those duties.
September 2014
The CCRA examination is specific to the role that CRAs play in the conduct of a clinical trial. The exam content
expects that you will have a basic working knowledge of general laboratory terms, tests, and procedures, as well
as how to perform basic math. It requires a general working knowledge of the roles and responsibilities of CRAs,
even if your employer does not require you to function in that role.
No two candidates come to the exam with the same knowledge base. Since experience and educational
backgrounds are unique, these differences must be taken into consideration when determining a study method.
Although some individuals may take the exam without any preparation, the majority become involved in some
form of exam preparation. Because the exams measure proficiency of the application of the knowledge required
to be an effective CRA, it is impossible to train or teach to the exam. The best preparation is to understand the
CRA knowledge requirements (see the Detailed Content Outline, provided above) and their application to clinical
research.
A clinical research associate who has met the eligibility requirements to sit for the examination should have the
knowledge needed to take and pass the examination. You might want to review the Detailed Content Outline for
topics or subtopics with which you are less familiar. If you find a particular area with which you are not familiar or
comfortable, that would be an area on which to focus your study or review. Or, you may want to do a surface
review of all the content areas, even those you believe you know well.
Because of the nature of the exam, there is not one comprehensive source to go to in order to study. However,
the Academy does recommend that you review the content areas covered on the exam by using the Detailed
Content Outline, which was provided above.
Steps to Preparing for the CCRA Exam

STEP 1: Assess your own professional experience. Read carefully through the Detailed Content
Outline (DCO) provided in this handbook. Compare the detailed description of knowledge and tasks, plus
the proportion of questions, to your own professional experience. Rate your relative skill level and
experience on a scale of 05 (0 = no experience) as an indicator of how prepared you are for each section
and where to invest more of your study focus in preparing for the exam. While you personally may have
limited experience with certain job functions due to your job description with your employer, success on
the exam requires you to demonstrate competency in all areas of the exam.
STEP 2: Start early and plan ahead. Dont wait to receive your Eligibility Notice. You must complete and
submit your detailed application at least three (3) weeks before the exam. Dont leave this until the last
minute! Focus some learning time on reading in every content category, but spend extra time reading in
those categories where your experience is limited. Match your study efforts in relation to the time you
have available and the specific study needs you have identified for yourself. Every exam candidate will
answer the same number of questions in every category.
STEP 3: Schedule your study time. If you decide to set up a study group, you should hold weekly
meetings that will take about two hours on one day/evening every week. Schedule flexible blocks of time
into your personal schedule. The key is not to memorize what you read, but to understand concepts
behind ICH/GCP and best practices in each knowledge category area to supplement your experience. Be
sure you understand how your SOPs differ in relation to ICH/GCP.
STEP 4: Organize your study notes. It may help you to organize your study notes, articles, summaries,
etc. in a binder using either the five (5) exam categories, or your own index. Let your experience guide
you in the content areas you are most comfortable with and focus more time in your weaker areas or on
those areas with which you are least familiar. Create flashcards to use as study aids.
September 2014
STEP 5: Choose the methods that are right for your study plan. Choose a mentor or colleague who
has more experience in the areas in which you are less familiar and ask him/her to review concepts with
you. As you perform your daily responsibilities, think about the underlying principles that lead you to take a
particular course of action.
STEP 6: Stick to your study groups plan. Pick a regular night and show up on time. Each of you has the
same goal, and everyone has something to offer. Sharing reading and exchanging book notes is a great
way to lighten the load. Study groups foster friendships and provide an incentive to stay focused on your
collective goal. Complete; dont compete.
STEP 7: Dont panic. Follow the excellent pre-exam advice that the Academy provides, and come to the exam
well-rested and prepared.
Further Study Tips

In addition to reviewing the ICH Guidelines, one way to review is to select texts and training materials you used
when first taking on the role of a CRA. You can select a publication that you may already have on your bookshelf,
or one that you can borrow from a colleague. You should select books or publications that cover topics found on
the Detailed Content Outline, the ICH Guidelines, or the tenets of GCP.
If you have time, take a workshop or attend a conference session on topics in which you need to become more
familiar. Any professional development courses that cover clinical research topics will add to your knowledge
base and therefore will help you prepare for the exam.
NOTE: The Academy does not sponsor or endorse any specific educational courseseven if the course
is advertised as a prep or review course for the CCRA exam. Courses titled this way are at the
discretion of the organization offering the course. Those creating the course have not had any inside information
about the exam. The same information that is included in this handbook to help you prepare is publicly available
to those creating educational content. Participation in these courses may help you learn or review topics covered
on the exam, but you should not expect them to directly cover exam content.
Test-Taking Strategies
Most adults havent taken a standardized exam recently. It can be helpful to be reminded of some key strategies
for how to approach a multiple-choice exam:
Read the entire question before you look at the possible answers.
Come up with the answer in your head before looking at the possible answers; this way, the choices
given on the test won't distract you from focusing on the question.
Read all the choices before choosing your answer so that you select the best one.
Eliminate answers you know are not correct.
There is no guessing penalty, so its always best to take an educated guess and select an answer if you
are uncertain of the answer.
Don't keep on changing your answer; usually your first choice is the right one, unless you misread the
question.
Go through the exam and answer the questions you know first. Mark the others for review and then go
back to those you skipped over. This will ensure that you dont lose time by focusing on one question you
arent sure about.
September 2014
Meet Eligibility
Requirements
Apply
Eligibility
Review
Schedule
Exam
Prepare
Take
Exam
Taking the Exam

It is important for candidates to understand their rights and responsibilities in the secure testing environment of
the Prometric test center. It is recommended that you review the full Policy on Testing Experience Issues.
Identification
To access a secure testing center you, must present proper identification (ID) containing your legal name. Your
legal name MUST match the first name and last name (middle names excluded) listed on your Eligibility Notice
(emailed from ACRP) and on the Appointment Confirmation (from Prometric). Your (ID) must meet each of the
following criteria:
government-issued AND
current (non-expired) AND
photo-bearing AND
signature-bearing identification (ID)
The photo must look like the examinee. Signature on ID must match the signature provided during the sign-in
process.
Examples of proper ID include passport, drivers license, state- or government-issued ID.
Exceptions will be made if:
name discrepancies are minor
parts of hyphenated names are missing
for candidates with two last/family names, one of the two last names appear
informal first names are used (James vs. Jimmy)
Any other differences will result in a candidate being denied from the testing center and result in forfeiture of all
fees paid.
Name changes (due to marriage, for example) are common, but can prevent a candidate access to the exam if
not properly presented. If a candidate is identified by a different name for the exam than that which is listed on the
ID, the candidate will be permitted to the Exam only if the ID is accompanied by a government-issued certificate
supporting the name change (e.g., a marriage certificate or divorce decree with previous and current name).
If the name listed with ACRP and Prometric is not your legal name, you must submit a Name Change Request to
certification@acrpnet.org immediately.
Time
The test center is serious about security so please observe the tips regarding entrance, below. Once seated, you
can follow a brief on-screen tutorial for navigating through the exam. Your exam will begin after the tutorial and is
three hours in length. When you have ended your exam, you will receive printed results immediately. Please
make sure that you have this important feedback before you leave as it is the only feedback you will receive
regarding your performance on the exam.
September 2014
Should you have any questions about the exam experience, please refer to the Certification Handbooks and
contact certification@acrpnet.org if you cannot find an answer. We want you to own your success and perform
at your best!
Test Center Guidelines

The test center is serious about security so please observe the tips regarding entrance, below. Once seated, you
can follow a brief on-screen tutorial for navigating through the exam. Your exam will begin after the tutorial and is
three hours in length. When you have ended your exam, you will receive printed results immediately. Please
make sure that you have this important feedback before you leave as it is the only feedback you will receive
regarding your performance on the exam.
Should you have any questions about the exam experience, please refer to the Certification Handbooks and
contact certification@acrpnet.org if you cannot find an answer. We want you to own your success and perform
at your best!
Prepare to bring the following to your appointment
Bring proper identification (ID). The first name and last name (middle names excluded) on your ID must
match the first and last name as they appear on the Appointment Confirmation. Your ID must be current
(non-expired), government-issued, and bear your photo and signature. The photo must look like the
examinee. Signature on ID must match the signature provided during the sign-in process. Examples of
proper ID include passport, drivers license, state- or government-issued ID. Any other differences will
result in a candidate being denied from the testing center and result in forfeiture of all fees paid.
Name changes (due to marriage, for example) are common, but can prevent a candidate access to the
exam if not properly presented. If a candidate is identified by a different name for the exam than that
which is listed on the IDs, the candidate will be permitted to the Exam only if those IDs are accompanied
by a government-issued certificate supporting the name change (e.g., a marriage certificate or divorce
decree with previous and current name).
Dress in layers so that you can make yourself comfortable in any temperature.
TIP: It is recommended to leave personal items at home. Any and all personal items will be locked in a locker.
Some examples include a purse, keys, wallet, calculators, watch, dictionary (except for non-electronic word-toword, English translation only) cell phone, all electronic devices, tissues, outerwear (heavy coats), food, and all
books and papers.
Resources available at the Test Center

You may use the following resources, issued only by the test center:
Hand-held calculator (also an on-screen calculator is available)
White board and dry-erase markers
Noise cancelling head set (Keep in mind that you are sharing a room with other examinees taking tests of
varying lengths.)
An abbreviations list for your specific exam is also available on screen
TIP: Please, please raise your hand at any time if your computer or any of the above tools are not functioning
properly!
Expect the Unexpected
September 2014
Plan to arrive 30 minutes prior to your appointment. If you are lost, or will be late, call the test center using
the phone number on your Appointment Confirmation.
If you miss or need to miss your exam appointment due to a medical emergency, illness, accident, or
death in the family, on Exam day, let us know as soon as possible at certification@acrpnet.org and
within seven (7) days of your scheduled appointment. With proper documentation, we can help you!
If you miss your scheduled exam appointment for any other reason, for example, lack of child care,
lateness due to work or traffic, your opportunity to test will be lost.
Rescheduling for any reason is permitted with a $50 fee, by contacting Prometric directly at 800-853-6769
or www.prometric.com/ACRP, if rescheduling occurs at least five (5) days prior to your exam
appointment.
MORE TIPS: These can help you focus on the exam and not the unexpected:
Know your travel route and traffic. Plan for a delay.
Prepare for child care
Get plenty of rest!
Exam Security
Exam content will be transmitted via encrypted electronic file to each exam site to ensure the security of the exam
questions. Computer-based testing allows for different versions of the exam to be offered and for changes in the
sequence of questions; this reduces the likelihood of misconduct and enhances the validity and integrity of the
exam. Each exam will be delivered via individual video-monitored testing carrelsboth to provide better privacy
while the candidate is taking the exam and to prevent unethical behavior.
Examinees will be presented with Prometric Test Center Regulations upon arrival at the test site. It is imperative
to read the information provided. Those who violate security will not have their exams scored or processed, and
will be required to leave the room immediately. To view regulations in advance, visit
www.prometric.com/Testing-Center-Regulations.
Removing or attempting to remove exam material or content from the test center will result in severe criminal and
civil legal consequences.
Exam Results
Computer-based testing provides participants with preliminary results immediately. On-site notices are preliminary
and candidates are not yet considered certified until official notification is received from the Academy.
Official confirmation of results will be mailed 30 days following the close of the exam window. Candidates who
pass the exam will be sent an official notice of Certification, a certificate, a CCRA pin, and Maintenance of
Certification information.
Candidates who do not pass the exam are advised to review the content area proficiency ratings and use this
information to assist in preparing for future exams.
Final exam results will not be given out over the telephone or by fax, nor will results be sent to employers,
schools, other individuals, or organizations under any circumstances. Candidates who pass the exam will be
added to the Academy Certification registry, unless this option was de-selected at the time of application. The
registry can be accessed at www.avectraacrp.com/Certlist.
Duplicate Certificates
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There is a $25 charge for a duplicate certificate if the request is made more than three months after the exam.
Requests may be made in writing by completing and sending the Duplicate Certificate Form to the Academy at
certification@acrpnet.org.
Exam Scores
Prometric, the Academys professional testing partner, scores all exams. One point is granted for each correct
answer. There is no penalty assessed for an incorrect answer; points are scored only for correct answers. The
number of questions answered correctly (or total points) is a candidates raw score.
A candidates raw score is converted to a scaled score. The "Total Scaled Score" will determine whether a
candidate has passed the exam. This scaled score is statistically derived from the candidate's raw score and can
range from 200 to 800. The passing scaled score for the CCRA exam is 600. The passing score reflects the
minimum amount of knowledge a committee of experts has determined to be appropriate for Certification,
according to accepted test development guidelines.
A criterion-referenced, standard-setting procedure and expert judgment are used to identify the passing point. The
Academy uses the widely accepted Modified Angoff method. A candidate's ability to pass the exam depends on
the amount of knowledge he or she demonstrates, not on the performance of other individuals taking the exam.
The reason for calculating scaled scores is that different forms or versions of the exam may vary in difficulty. As
new versions of the exams are introduced, a certain number of questions in each content area are replaced by
new questions. These changes may cause one version of the exam to be slightly more or less difficult than
another version.
To adjust for these differences in difficulty, a statistical procedure called "equating" is used. The goal of equating
is to ensure fairness to all candidates. In the equating process, the minimum raw score (number of correctly
answered questions) required to equal the passing scaled score is statistically adjusted (or equated). For
instance, if the exam is determined to be more difficult than the base form of the exam, then the minimum raw
score required to pass will be slightly lower than the passing scaled score. If the exam is a bit easier, then the
passing raw score will be slightly higher than the passing scaled score. Equating helps ensure that the passing
scaled score represents the same level of knowledge, regardless of which version of the exam a candidate takes.
A candidate scoring below the minimum scaled score has not been successful on the exam and cannot be
certified. The exam is not scored on a curve. There is no predetermined number of candidates permitted to pass.
Your score does not depend on the other candidates testing with you that day.
Note: The passing point set for the exam cannot be appealed. To score one point below the passing point is to be
unsuccessful on the exam; to score at the passing point or higher is to pass the exam. A score higher than the
passing point is not an indication of a higher proficiency in the subject matter.
Specific questions on the exam and/or answers to exam questions will not be discussed or released. Due
to the security of the item bank and because exam questions can be used on various exams, exam questions will
not be discussed with candidates and candidates may not have access to the exam or their answers.
Scaled Scores and Score-Reporting FAQs

Commonly asked questions and information about scaled scores and score reports is provided below.
1. Why are scaled scores used?
They are used to provide a consistent scale of measurement, so that from one test administration to the next, the
same scaled score represents the same level of knowledge. Each exam administration has multiple exam forms
in use, and some forms may be more difficult than others. A scaled score keeps the level of knowledge required
to pass constant.
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2. Why not just use the number of items answered correctly?

This may provide useful information about your performance on different parts of the test, but does not take into
account the difficulty of the items.
3. Is a scaled score the same as a percentage score?
No. Calculation of a percent correct is a way to convert a raw score to another scale, but a scaled score is not
the same as a percent correct. You could calculate percentage scores by dividing the number correct by the total,
for example, a raw score of 9 in a category with 15 total items relates to 60% correct, but a scaled score of 600
does not relate to 60% correct.
4. How should I interpret my performance on the category scores?
When reviewing your proficiency for the major categories, bear in mind that all categories are not equally difficult.
Those areas indicating below proficient are areas where additional study or review would be helpful.
5. Why dont I get a percentage score on my report?
Similar to a raw score, converting your score to a percentage score would not take the difficulty of the items into
account.
6. How is the scaled score computed?
To calculate a scaled score, the raw score required to pass is first set equal to 600. An analogous situation is with
temperature: 0 degree and 32 degrees both represent freezing on different temperature scales. Raw scores
below the passing point are converted in linear fashion to scaled scores below 600; those above the passing point
are similarly converted to scaled scores above 600.
7. Why do I need a 600 to pass the test?
The amount of knowledge required to pass the test is based on the judgments of the content experts who are
certified in the job role tested. The raw score required to pass relates to the number of correct answers that a
minimally competent (borderline) candidate would be expected to provide, and this raw score is set equal to 600
scaled score units. Different raw scores may be required of different test forms, because all examinations are not
equally difficult. The scaled score of 600 required to pass indicates that, while a different number of correct
answers may be required from one administration to the next, the passing point for all examinations represents
the same level of knowledge.
How are Certification Exams Developed?

In response to the ACRP Membership's numerous requests for professional recognition, two exam committees
were established in 1990; by 1992, the first Certification exams were developed with the assistance of a
professional testing organization. The committeesone each for CRAs and CRCsidentify areas of competency
for testing, develop appropriate test questions, and assist with validation of the exams.
It is important to note that the Academys programs are accredited by the National Commission for Certifying
Agencies, which sets internationally recognized standards for the development and operation of certification
programs. The standards assure that a program is valid, reflects current practice, and treats candidates fairly.
The development of Certification examinations begins with a Job Analysis, which is a survey that goes to
members of a profession to create a definitive description of the tasks required to perform a job role and the
knowledge needed in order to complete those tasks. A Job Analysis Survey is typically conducted every five to
seven years to assure the exam is testing current practice in a job role.
In 2010, the Academy updated its CRA Job Analysis with a survey sent to thousands of clinical research
professionals, 3,636 of whom responded. The results of the survey identified for the Academy what to include on
the Detailed Content Outlines (DCOs) for each job role. Those task and knowledge statements that the majority of
September 2014
CRAs said were essential to their job role and that they performed frequently are covered on the exam. The
results are then incorporated into the CRA DCO.
Individuals who are already certified as a CRA are then trained to write test questions. We call these volunteers
Subject Matter Experts, or SMEs. All questions must test knowledge and skills as defined by the DCO, and
must be referenced to specific areas of ICH Guidelines, as described in our candidate handbooks. Once the
SMEs have written draft questions, the questions go to the CCRA Exam Committee for review. This process is
constantly in motion, with new questions being written, current questions being reviewed, and older or
nonperforming questions being retired from the item bank.
The CCRA Exam Committee consists of a separate group of currently practicing, certified CRAs who review,
edit, discuss, and rewrite the draft test questions. Many draft test questions are discarded in the process. Others
are completely rewritten or heavily edited. Each question must meet minimum standards for applicability to the job
role. All Exam Committee members must agree that the answer keyed as correct is, in fact, the only correct
answer possible.
Once a draft question is approved by the Exam Committee, it then becomes a pre-test question. All questions are
pre-tested before they are counted toward a candidates score. The exams given to candidates are 125 questions
long, and 100 of them count toward the candidates score while 25 are pre-test questions. This means the
Academy is collecting statistical data on the pre-test items to see if they are well-constructed enough to appear on
the exam as a scored item. Hundreds of candidates answer a pre-test question before it can be determined if it
can be used toward a candidates score.
Once enough data have been collected, analyses are performed on the item statistics in conjunction with the
Academys professional test development partner to see if items have performed well enough to be used. If they
have not performed well (for example, if many candidates are choosing the wrong answer; or each of the four
answers is being selected equally, which indicates test-takers are guessing; or candidates who score well on the
exam overall are selecting a wrong answer), then the questions are set aside for further review and rewriting, or
they may be discarded. Only those questions that demonstrate they are fair to the test taker and identify
proficiency in a candidate are used.
Several diverse groups of CRA volunteers are used to write the questions, review the questions, select questions
to be pre-tested, and select and review questions that actually appear on the exam. The Academy follows a
process that meets international standards for test development and works with a highly regarded testing partner.
To date, more than 27,000 clinical research professionals have been Certified by the Academy. On average, 72%
of those who sit for an exam pass it.
Reliability Measurements
After every Certification exam, the Exam Committees review the results with the assistance of Prometric, one of
the testing industry's leading firms. Each item is analyzed for appropriate psychometric characteristics. Those
items with poor statistical results are reviewed by the appropriate Exam Committee to ensure that they have been
scored properly. Participant feedback regarding the exam and its contents is also reviewed and taken into
consideration when reviewing the exam and future test items.
Pass
Exam
September 2014
Achieve
Certification
Maintenance of
Certification
Maintenance of Certification
Once a candidate has achieved Certification, it is valid for two (2) years. In order to continue to be certified and to
continue to use the designation after two (2) years, certificants will need to apply for Maintenance of Certification.
The Academy requires periodic Maintenance of Certification to ensure that individuals who hold a CCRA
credential maintain their ongoing commitment to professional development in their selected area of practice.
Through the Maintenance of Certification requirements, certificants demonstrate expansion and reinforcement of
their knowledge of current practice.
The Academy supports this purpose by requiring appropriate and relevant continuing education activities to
enhance the professional development of certificants. The Maintenance of Certification program also serves to
encourage and recognize individuals who participate in ongoing professional development.
CCRAs must maintain every two (2) years from the time of original Certification. The two-year Maintenance of
Certification cycle is based on the frequency of change in the clinical research field. Maintenance of Certification
requires the completion of 24 documented hours (referred to as points). These points can be earned through
professional development and/or continuing involvement. Updated information is available at
www.acrpnet.org/Maintenance. Also view the full Policy on Continuing Competency and Maintenance for
CCRA-CCRC-CCTI.
Maintenance Requirements
To maintain Certification successfully, CCRA certificants must:

1. Satisfy the requirements using one of the two (2) options listed below.
2. Document the required points on the Maintenance application (online or printable form).
3. Submit the completed application together with appropriate payment by the expiration date.
Maintenance requirements are outlined more specifically in the Maintenance Handbook.
Maintenance of Certification Two Options

Participation in Professional Development:
At least 12 points from Research topics

Option
1
No more than 12 points from Disease/Bodily

Systems/Healthcare topics
Option
2
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Continuing Involvement Points

(see chart)
Total
Points
Required
No more than 12 points

(see chart in Continuing
Involvement section)
24
Pass the current form of the CCRA exam prior to your Certification expiration date
Frequently Asked Questions (FAQs)

How will I know if my exam application was received?
An e-mail confirmation is automatically sent once payment is applied. Applicants will also be sent an e-mail that
confirms that the application has entered the eligibility review process.
NOTE: Confirmations of receipt do not confer eligibility. A separate notification will be sent regarding an
eligibility decision. Please take any necessary steps to prevent filtering of ACRP e-mails.
How will I know if I am eligible to take the exam?
An e-mail will be sent within ten (10) days after receipt of the application to notify you of your eligibility status or
any deficiencies that may exist.
What should I bring to the test center?
Bring an appropriate identification, as described in this handbook. Online and handheld calculators will be
provided.
What happens if I need to cancel the exam?
If a candidate has already scheduled an appointment with Prometric, then:
1. Contact Prometric to cancel the appointment, at www.prometric.com/ACRP or 800.853.6769
2. Pay the appropriate cancellation fee to Prometric (if applicable)
3. Notify the Academy in writing at certification@acrpnet.org once the appointment is cancelled
If the candidate has not yet scheduled an appointment with Prometric, then the candidate should notify the
Academy in writing at certification@acrpnet.org.
If you cancel at least five (5) days prior to the exam, you will receive a refund of the exam fee only. No refunds
are available fewer than five (5) days prior to the exam.
What if I need to retake the exam?
An exam may be attempted only once during each testing window. Candidates may reapply for the exam and
reattempt to take it during any future testing window.
What happens if I miss the application deadline?
All applications must be received by the Academy (not postmarked) by the application deadline. Faxed
applications will be accepted. If you miss the deadline, you may reapply when the applications become available
for the next scheduled exam date. Your application will not be returned to you.
What tools does ACRP have available to help me prepare for the exams?
The Detailed Content Outline (DCO), and therefore the content of the CCRA exam should be used to build
your study plan.
An electronic, downloadable ICH Guidelines and Declaration of Helsinki Booklet is available, online as well.
Optional Exam Preparation options are available for purchase online at www.acrpnet.org/examprep.
What is the Academys Maintenance of Certification process?
The Academy requires periodic Maintenance of Certification to ensure that individuals who hold a CCRA
credential maintain their ongoing commitment to professional development in their selected area of practice.
Through the Maintenance of Certification requirements, certificants demonstrate expansion and reinforcement of
their knowledge of current practice.
September 2014
CCRAs must maintain every two (2) years from the time of original Certification. Maintenance of Certification
requires the completion of 24 documented professional development and/or continuing involvement points. A
minimum of 12 of the 24 hours completed must be from participation in Professional Development activities
specific to research topics. Maintenance of Certification may also be achieved by completion of a total of 24
documented points, with a maximum of 12 points coming from continuing involvement activities. For a complete
listing of continuing involvement activities, please visit: www.acrpnet.org/PDF/maintenance_handbook.pdf.
View the full Policy on Continuing Competency and Maintenance for CCRA-CCRC-CCTI.
What records of professional development or continuing involvement activities should I keep?
Copies of certificates should not be submitted with the Maintenance of Certification submission. Certificants
should retain all certificates with their records in case of selection for a random verification. The Academy will
request these records if needed. All professional development and/or continuing involvement activities submitted
for Certification maintenance are subject to review and approval. The Academy reserves the right to request
additional information and to verify any documentation, including academic records. Credit may be denied for
professional development or continuing involvement activities that fail to meet the guidelines established in this
policy.
What type of points may I use to maintain?
The Maintenance of Certification Handbook explains that acceptable courses for earning professional
development points include those offered by:
All state and national nursing associations;

American Council on Pharmaceutical Education (ACPE);
Accreditation Council for Continuing Medical Education (ACCME); and
Other national healthcare-related associations (respiratory therapy, medical technician, etc.)
What are examples of unacceptable professional development points?

Attendance certificates for programs that do not offer professional development points with a provider number, as
well as, for example:
CPR or BLS training courses

Blood pressure training courses
Courses that focus on self-improvement, changes in attitude, computer skills, investments, and liberal arts
What happens if I do not maintain my Certification?

Individuals who fail to properly maintain their Certification(s) will be decertified for failure to maintain by the
specified deadline. You will receive a two-week grace period in which you may maintain with submission of the
required professional development and/or continuing involvement points. If you do not respond by the end of the
grace period, you will be decertified and will receive notification of this action.
Can I reinstate my Certification if it has expired?
A certificant who has had a credential revoked due to not meeting the Maintenance of Certification requirements
may re-apply for Certification by examination. The individual must meet the current eligibility requirements, pay all
required fees, and successfully pass the exam.
September 2014
ACADEMY POLICIES
Certification-Related Policies
ACRP / APCR Code of Ethics and Professional Conduct (website link only)
Non-Discrimination Policy
ACRP, APCR, and the Academy shall not discriminate against any member, certificant, or individual applying for
membership or certification on the basis of gender, race, color, national origin, sex, age, religion, marital status,
sexual orientation, political affiliation, citizenship status, physical challenge, disability, veteran status or any other
status or condition that is protected by applicable law.
View the full Non-Discrimination Policy.
Discipline and Complaints Policy

ACRP enforces the ACRP/APCR Code of Ethics and Professional Conduct for all CRC, CRA, CTI, and PI
certificants and individuals in the process of obtaining CRA, CRC, or PI Certification.
ACRP will investigate reported violations of the Code of Ethics and Professional Conduct. Complaints regarding
alleged violations should be reported to ACRP in writing, and should include a detailed description of factual
allegations supporting the charges and any relevant supporting documentation.
Information submitted during the complaint and investigation process is considered confidential and will be
handled in accordance with ACRPs Confidentiality policy. ACRP adheres to due process principles. Adverse
disciplinary decisions made by ACRP (or its committees) may be appealed.
View the full Discipline and Complaints Policy.
Certification Mark Use

ACRP and the Academy, grant limited permission to individuals who have met all of the Certification eligibility
criteria, passed the applicable exam(s), or maintained their certification per the Academys maintenance
requirements, and received notification of certification from the Academy to use the CCRA, CCRC, CCTI, or
CPI designations that have been granted to them.
The CCRA, CCRC, CCTI, or CPI designations are registered trademarks in the United States, Canada,
and India (CPI only) and their use is protected by applicable trademark law.
This limited permission allows only individuals who are currently in good standing with the Academy to use the
designations as part of ones professional title. View full Policy on Use of the Certification Mark.
Revocation of Certification
The Academy may revoke Certification, or take other disciplinary or legal action, in the case of falsification or the
provision of misleading or incomplete information in the CV or statement of experience. ACRP may also revoke
Certification, or take other disciplinary or legal action, in the event that an individual is in violation of the
ACRP/APCR Code of Ethics and Professional Conduct or has regulatory or professional restrictions placed on
his or her clinical research practice or professional license. ACRP will adhere to due process principles. If a
certificant is notified of revocation, he or she will also be notified of the appeal process.
View the full Discipline and Complaints Policy and Appeals Policy.
September 2014
Policy on Release of Certificant Information

Certification is a voluntary credentialing process with the goal of protecting the public. The purpose of certification
is to ensure the public that Academy certificants have met all eligibility criteria and mastered particular knowledge
to provide so as to perform the duties essential to their role in clinical trials safely and effectively.
Names of individuals holding Academy certifications, which have not opted out, shall be available to the public via
the Academys online Certification Registry or inquiry to Academy staff. This publically available information shall
be limited to confirming an individual is currently certified or individual is not certified.
Any further details regarding an individuals certification status will only be released upon receipt of a signed
released signed by the individual about whom information is being sought. Upon receipt of the signed release the
Academy will release the following information only:
Name of the individual

Name of the certification program
Initial certification date
Certification expiration date
Certification number
Confidential information that will not be released, even if a signed release is provided, includes: names of
candidates for certification; names of individuals who are not successful on the examination; and individual test
scores.
Confidentiality
The Academy protects the confidential information of applicants and certificants. In addition to personal
information submitted in the application, application and eligibility status and exam results are also considered
confidential. Unless otherwise required by law, confidential information will be released only to the individual
applicant/certificant unless a signed release is provided.
Verification of Credentials
An individuals Certification status may be verified through the searchable Academy registry on the ACRP website
unless that individual has opted to be excluded from this public listing. Written verification may be requested only
by contacting the Academy at certification@acrpnet.org
View the full Policy on Release of Certificant Information.
Policy on Continuing Competency and Maintenance for CCRAs

The goal of the Certification process is to ensure, as much as possible, the continuing competence of each
certificant and maintain the professional standard of those engaged in clinical research. There are a number of
professional activities that can contribute to that goal.
The purposes of the Continuing Competency requirements established by the Academy are that CCRAs continue
to:
obtain current professional development information;
explore new knowledge in specific content areas;
master new clinical research-related skills and techniques;
enhance approaches to effective clinical research, both within their specified job role and beyond;
further develop professional judgment;
conduct clinical research in a safe and ethical manner.
September 2014
The Academy expects that clinical research professionals engage in lifelong development to maintain and
improve knowledge and skills for competent practice. This includes continuous self-assessment to identify
professional strengths and learning needs, establishment of short- and long-term goals for individual professional
development, and selection of appropriate professional development to meet these goals.
Candidates for Maintenance should choose those professional development activities that provide them with the
most benefit, keeping in mind that the length and rigor of a program contribute to its value. Advance planning for
Professional Development enables candidates to choose more appropriate courses and also to control expenses
more effectively. Professional development programs provide one of the main methods for keeping up with
professional practice.
Maintenance of Certification is required every two (2) years. Each candidate for Maintenance must demonstrate
that he/she meets the current requirements in order to successfully recertify and be permitted to continue to use
the designation.
To successfully maintain Certification, each candidate for Maintenance must submit 24 points as part of the
Maintenance application. The point requirements vary by program.
View the full Policy on Continuing Competency and Maintenance for CCRA-CCRC-CCTI.
Application-Related Policies
Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination
When an applicant is granted eligibility to take an Academy certification exam, that eligibility is granted for the
exam period for which application was made. All eligible candidates are expected to schedule an exam
appointment for, and take the examination during, the exam period for which eligibility was granted. The
Academy does recognize that occasionally circumstances may prevent a candidate from testing in the originally
scheduled exam period, or may require the candidate to retake the examination. Under certain circumstances,
the Academy will grant eligibility for one additional exam period beyond the original period for which the candidate
has applied.
Transfers
If a candidate is unable to test during the exam period for which he or she was originally approved, the candidate
may request a one-time transfer to the next available exam period at no additional cost.
Transfer will only be made to the next available exam period. The transfer request can be made at any time
between the time of initial approval and the last day of the exam period. The candidate must request a transfer by
completing the Exam Transfer Request form. The candidate must cancel any previously scheduled appointments
with the testing agency in order to take advantage of this option.
Candidates are allowed one transfer only. If a candidate has already transferred the exam one time, the candidate
will not be able to do so again.
Transfer of eligibility and associated fees will be applied only to the original candidate and are not transferable to
another person, even if paid for by a third party. Exam fees transferred may be used only toward the next exam
and not toward other products or services.
No Testing Appointment Scheduled
September 2014
If a candidate does not schedule an appointment for, or take, the exam in the original exam period for which he or
she was approved, and the candidate does not request a transfer before the close of the original exam period for
which he or she was approved, the candidate will not be refunded the exam fee.
Candidates will need to submit a new application, together with all current fees, to continue their pursuit of
certification. Such reapplications will be subject to all eligibility criteria in effect at that time.
Exam Cancellations
Occasionally, a candidate intends to test but circumstances prevent him or her from doing so. Candidates are
permitted to cancel a scheduled exam up to five (5) days before the scheduled appointment by contacting the
testing agency directly. Based on how far in advance the candidate cancels the scheduled appointed, there may
be fees associated the appointment cancellation.
It is mandatory that the candidate cancel their exam with both the testing agency and with the Academy.
Candidates are to contact the testing agency directly first and then must contact the Academy. Only the
candidate may request a cancellation, regardless of whether the exam fee was paid by the candidate or another
party.
Cancellation requests received fewer than five (5) calendar days prior to a scheduled exam appointment will not
be honored. Once an exam appointment is cancelled, a candidate may be eligible to request a Transfer to the
next exam period.
No Shows
If a candidate schedules an exam appointment and fails to take the exam, he or she forfeits all fees.
If a candidate arrives late for a scheduled exam appointment, entrance to the testing area is at the discretion of
the Test Center Administrator. A candidate may not be allowed to test and will not be eligible for a refund.
Refunds will not be given for exams that are missed because a candidate was not able to locate the testing center
or arrived late.
Emergencies
If a candidate is unable to keep his or her exam appointment due to an emergency situation that arises within the
five (5) days prior to his or her exam appointment, the candidate is required to submit an Emergency Cancellation
Form and official documentation to the Academy in order to avoid forfeiting fees. This information must be
received by the Academy within seven (7) calendar days after the candidates scheduled exam appointment. The
following situations will be considered with documentation:
Emergency room visit or hospitalization

Severe medical condition requiring hospitalization (e.g., spouse, child/dependent, parent, grandparent,
sibling)
Death of an immediate family member (e.g., spouse, child/dependent, parent, grandparent, sibling)
Jury duty
Call to active military duty
Refunds
If a candidate must cancel an exam appointment and is eligible to transfer his or her eligibility to the next exam
period, the candidate may instead elect to receive a refund of exam fees. The only portion of the total amount
submitted that will be refunded is the exam fee, provided that the request for cancellation is received at least five
(5) calendar days prior to a scheduled exam appointment and the exam appointment has been cancelled .
Application fees are non-refundable.
September 2014
Refunds are not available to candidates who do not schedule an exam and fail to request a transfer, who cancel
within five (5) days of the exam and do not provide sufficient documentation of an acceptable emergency, or who
fail to show up for a scheduled exam appointment. Refund requests will be considered only if made by the
candidate.
Applicants who do not meet the eligibility requirements for the exam (i.e., those who are ineligible), or who are
ineligible due to an incomplete application, will receive a refund of the exam fee only, within three weeks of the
final ineligibility notification.
Refund requests can be made by the candidate only. Employers supporting a candidates fees cannot request a
refund for fees paid to the Academy. Any refund will be sent to the party who initially made payment to the
Academy. If payment was made by credit card, that card will receive the credit. If the payment was made by
check, the Academy will mail a refund check to the original payer.
Re-Examination
Candidates who do not achieve a passing score on the certification examination will be allowed to re-take the
exam in the next available exam period only without submitting a new application for a reduced re-examination
fee.
If the candidate is not successful on this re-take examination, he or she will need to complete a new application
and pay all fees in place at the time for any subsequent exams.
If a candidate chooses to transfer his or her first exam opportunity and, subsequently, does not pass, he or she
will need to complete a new application, meet all eligibility criteria in effect at that time, and pay all fees in place at
the time for any subsequent exams.
Candidates who do not achieve a passing score on their second attempt or who are unable to test again during
the next exam period must submit a new application, together with all current fees, to continue their pursuit of
certification. Such reapplications will be subject to all eligibility criteria in effect at that time.
September 2014
Eligibility-Related Policies
CCRA Eligibility Policy
All applicants for the Certified Clinical Research Associate (CCRA) program must meet all of the eligibility
requirements stated in the CCRA Candidate Handbook and on the application form itself in order to be approved
to take the CCRA examination.
Applicants are required to submit both
1) a copy of a current curriculum vitae (CV) or resume and
2) a copy of job descriptions for each of those positions used to demonstrate eligibility
with enough detail so as to sufficiently document and demonstrate achievement of the required minimum number
of hours of employment performing the Essential Duties of a Certified Clinical Research Associate.
The CCRA Essential Duties are defined as:
Verify that the research site personnel, including the investigators, are conducting the study according to
the clinical protocol, Good Clinical Practices, and regulatory requirements;
Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC;
Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source
documents (source data verification);
Review accuracy and completeness of site records (site study file, query resolution, and other data
collection tools);
Verify Investigational Product accountability;
Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial
management tracking system);
Conduct routine monitoring visits on behalf of the clinical trial sponsor.
In addition, the CRA must operate independently from the investigative site staff.
Applicants must document a cumulative, minimum of number of hours of employment performing the Essential
Duties, based on his/her highest level of education completed.
Highest Level of Education Completed
Minimum Hours Performing Essential Duties
Bachelors degree (or higher) OR

Registered Nurse (RN)
3,000 hours
Associates degree
4,500 hours
Other, such as LPN, LVN, Medical Assistant, Lab

Technician
OR
High School diploma
September 2014
6,000 hours
The Academy considers applicants who have completed a formal clinical research education program that meets
the following standards to have achieved a valid substitute for 1,500 hours of the required professional experience
performing the Essential Duties.
Acceptable programs must:
Be at least 216 hours in length and
Cover content that substantially maps to the topics found on the current CCRA Detailed Content Outline
(DCO) and
Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation
(CHEA) or be authorized by the appropriate regulatory authority in the country in which the program
operates.
If an applicant submits an application using an educational program as a substitute for 1,500 hours of work
experience performing the Essential Duties, then the following information must be included on the applicants CV
and a certificate of completion/transcript must also be submitted:
Name of school
City and country in which the school is located
Program title
Name of organization that accredits the institution providing the program
Dates attended (From-To)
The Academy reserves the right to verify any and all employment information submitted on an applicants CV or
job description at any time during the process of certification or thereafter. If an applicant is found to have falsified
or misrepresented his/her documentation, it is grounds for revocation of eligibility and/or certification status.
Policy on Denial of Eligibility

All applicants who seek eligibility to take one of the Academys certification exams, the Certified Clinical Research
Coordinator (CCRC), Certified Clinical Research Associate (CCRA), or the Certified Physician Investigator
(CPI), must satisfy the minimum eligibility requirements as outlined in the appropriate candidate handbook for
each designation. Applicant eligibility is reviewed individually. Each applicant is automatically afforded review by
three separate reviewers, if necessary, during the eligibility review process.
Eligibility for approval to take an Academy certification exam may be denied when any part of the application
and/or disclosure statement is incomplete, illegible or does not contain the correct fees.
Eligibility for approval to take an Academy certification exam may also be denied when an application purporting
to represent and demonstrate how the applicant meets the established eligibility requirements is found to be
incomplete, and/or does not substantiate or properly demonstrate the applicants achievement of the minimum
eligibility requirements.
When any application for eligibility to take an Academy certification exam is denied, the applicant will be notified in
writing, typically via email, and given seven (7) business days to correct and submit that which is necessary to
properly complete the application process and verify minimum eligibility requirements as outlined in the
Academys certification handbooks.
If time permits and all documentation is in order, the candidates application will be processed and eligibility
granted for the examination window originally requested by the candidate. Should this process take the applicant
within three (3) business days of the start of the examination window he/she requested, the candidate will be
granted eligibility for the next available examination window.
September 2014
Regardless of the items the candidate must supply, or the time line in which materials are submitted, the
candidates application may only be transferred forward to the next examination window once, based on the
examination window for which the candidate originally applied.
If the applicant cannot supply appropriate and sufficient eligibility documentation or an eligible candidate does not
take the examination by the start of the next examination window, he/she will forfeit all fees. The applicant will
need to reapply and submit all current fees in order to be consider again for eligibility.
September 2014
Policy on Appeal of Denial of Eligibility

The Academy of Clinical Research Professionals (the Academy) makes every attempt to make fair and
accurate eligibility decisions based on the information provided by the applicants. An appeal procedure is
available to any applicant who has applied for certification by the Academy and who wishes to contest any
adverse decision affecting his or her application for certification status. Any individual who does not file a
request for an appeal within the required time limit shall waive the right to appeal.
1. The passing score for the exam, or the process used to establish that passing score, which may
result in failure of the certification examination.
answers. However, candidates may not have access to the test form, their answers, or the answer key.
Appeal Process
All complete applications submitted for certification are afforded three (3) levels of review automatically, as part of
the standard review process. All applicants are selected by a reviewer, based on the first letter in the applicants
last name. Reviewers can communicate directly with applicants via email to obtain additional or clarifying
information to make an eligibility determination. If the first reviewer determines the candidate is ineligible, the
applicant will be notified by email with an explanation of the deficiency identified. The application is then
automatically forwarded to a second reviewer (except for cases of incomplete application/ documentation), based
on the first letter of the applicants last name.
The second reviewer begins review of the application in its entirety. The second reviewer can communicate
directly with applicants via email to obtain additional or clarifying information to make an eligibility determination.
If the second reviewer determines the candidate is ineligible, the applicant will be notified by email with an
explanation of the deficiency identified. The application is then automatically forwarded to the Director of
Certification for the final level of automatic review.
The Director of Certification reviews the application in its entirety. The Director of Certification can communicate
If Director of Certification determines the candidate is ineligible, the applicant will be notified by email of the final
denial with an explanation of the deficiency identified.
Upon receipt of the notice of denial by the Director of Certification, the applicant has the option to submit a final,
written notice of appeal to the Academy no more than 7 (seven) days following receipt of notice of denial by the
Director of Certification.
In the written notice of appeal, the applicant shall submit additional, written, factual documentation to support
his/her appeal with an explanation of why he or she believes the reviewer(s) erred in his/her decision. No new
documents pertaining to the applicants eligibility shall be accepted during the appeals process. The applicant
shall bear the burden of proving the denial of eligibility was based on erroneous factual determination of the
reviewer.
The Academy Board of Trustees will review the candidates application and accompanying documents
and the appeal letter and make a determination within fifteen (15) days of receipt of the appeal. The
September 2014
applicant will be notified via hard-copy mail of the decision of the Academy Board of Trustees within
seven (7) days of their vote and the decision shall be final.
September 2014
Exam Appointments, Testing Experience and Exam Outcomes

Policy and Procedure on Special Accommodations
In compliance with the provisions of the Americans with Disabilities Act (1990) and Title VII of the Civil Rights Act,
as amended (42 USCG 2000e, et.seq.), the Academy of Clinical Research Professionals (ACRP) provides
qualified candidates with a disability, who supply appropriate documentation, reasonable and appropriate
accommodations in order for the candidate to take the CCRC, CCRA, or CPI exam. The Academy follows
the Principles of Fairness set forth by the Institute for Credentialing Excellence.
Under the ADA, a disability is defined as a physical or mental impairment that substantially limits one or more
major life activities. Examples of major life activities include:
Caring for ones self

Performing manual tasks
Walking
Seeing
Breathing
Learning
Working
Qualified Candidates with a Disability

A "qualified individual with a disability" is one who has a disability and satisfies all the requisite skill, experience,
education and other requirements for certification and, with or without accommodations, can perform the essential
duties required of his/her job role. A person must be a "qualified individual with a disability" to be protected under
the ADA.
Reasonable Accommodation
Reasonable accommodations provide a candidate with a disability a fair and equal opportunity to demonstrate
his/her knowledge and skill in the essential duties being measured by the exam. Reasonable accommodations
are decided upon based on the individual's specific request, disability and documentation submitted as well as the
appropriateness of the request. Reasonable accommodations do not include steps that fundamentally alter the
purpose or nature of the exam.
Proper Documentation
The candidate must submit documentation provided by an appropriate licensed professional or certified specialist
who diagnosed the disability and is recommending reasonable accommodations. The documentation must be
submitted on the professional's letterhead. The documentation must provide a diagnosis of the disability and the
test(s) used to determine the disability. The professional must also recommend specific accommodations. These
recommendations should be based on testing that is not older than four (4) years prior to the application. The
confidentiality of all documentation submitted by the candidate is protected.
September 2014
Procedure
A candidate requesting special accommodations must do so in writing by completing the Request for Special
Accommodations FormParts 1 and 2 and the request must accompany a completed application for
Certification. The request must include proper documentation from a licensed professional or certified specialist
who diagnosed the disability condition AND the specific testing aids or modifications being requested.
Accommodations, if approved, will be provided at no additional charge.
The Academy will review the request and provide a response in writing to the candidate along with his/her
eligibility determination. If the candidate has been deemed eligible to take the exam, the Eligibility Notice will
include the accommodations that have been approved.
All special accommodation forms and related documentation are confidential and will not be released without the
written consent of the candidate.
Documentation Requirements
It is the responsibility of the candidate to ensure that all required forms and supporting documentation are
submitted to the Academy. A request for special testing accommodations will not be reviewed until all
documentation is received. Required documentation includes:
A completed Request for Special Accommodations form. This form consists of two sectionsone to be
completed by the candidate, and one to be completed by the healthcare professional.
Evaluation of the candidates disability, to be completed by the healthcare professional. Note: The
healthcare professional must be a licensed or otherwise qualified practitioner whose credentials are
appropriate to diagnose and evaluate the specific disability. Candidates requesting accommodations for
learning disorders or mental disabilities must be diagnosed by a psychiatrist, psychologist, or other
professional with a minimum of a Masters degree, with credentials recognized as competent to diagnose
a mental disorder or learning disability.
If the candidate did not receive special accommodations during his/her years of higher education, a
written explanation of why accommodations are being requested now is required. This is completed by
the healthcare professional.
September 2014
Request for Special Accommodations FormPart 1

Name: ________________________________________________________________________________
Title: _________________________________________________________________________________
Organization: __________________________________________________________________________
Address: ______________________________________________________________________________
City: _________________________________ State: _________________ Zip/Postal Code: ____________
Country: ____________________________________ Phone: ___________________________________
E-mail Address: _________________________________________________________________________
Requests for Special Accommodations must be received with an application to take the examand no
less than 30 days in advance of the start of the testing window.
Please describe your disability: ____________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Date disability was diagnosed: _____________________________________________________________
Please list any previous accommodations received:
Date of
Type of Accommodation Received
Accommodation
Name of Institution / Organization

Providing Accommodation
I understand that the Academy of Clinical Research Professionals (the Academy) will use the information
obtained by this authorization to determine eligibility for a reasonable accommodation in regard to the CCRC,
CCRA, or CPI examination, by reason of my disability. I understand that the Academy reserves the right to
make additional inquiries regarding my disability and previous accommodations before making a determination as
to whether to provide the accommodations I have requested above. Under penalty of perjury, I declare that the
foregoing statements, and those in any required accompanying documents or statements, are true. I understand
that false information may be cause for denial or revocation of certification. I hereby certify that I personally
completed the above form, and that I may be asked to verify this information at any time.
Candidate Signature: _______________________________________________ Date: ____________________
I hereby authorize and request the health care professional identified below to release the information requested
by the Academy relating to my disability and the accommodation appropriate to my disability to sit for the CCRC,
CCRA, or CPI examination.
Dear Healthcare Professional:
The individual identified above is requesting accommodation to sit for the Certified Clinical Research Coordinator
(CCRC), Certified Clinical Research Administrator (CCRA), or Certified Physician Investigator (CPI)
September 2014
Examination. The Academy of Clinical Research Professionals (the Academy) policy requires that candidates
requesting special testing accommodation submit current documentation of the disability from an individual
qualified to assess the disability.
The individual listed above is requesting that you provide such documentation. The following must be completed
by you:
1) The remainder of this form (Part 2)
2) An evaluation, on professional letterhead, that includes the following information (if submitting an existing
report, it must have been written within the past 4 years):
a. Confirmation of diagnosis and functional impairment
o
Date (month/day/year) of first consultation
Date (month/day/year) the individual was last seen by you
Diagnosis, summary history, and course of the disability
Individuals current functioning and limitations in major life activities
For learning disabilities or mental disorders, the DSM classification of the diagnosis
(Diagnostic and Statistical Manual of Mental DisordersIV TR). Notes: DSM classification
does not guarantee classification as a disability under ADA, and therefore, does not
guarantee accommodation by ACRP; ACRP will not accept a diagnosis of Learning Disorder
that was made before the individual was 18 years old, if the last diagnosis date is more than
3 years old.
Diagnostic tests administered, scores, and interpretation of scores.
Confirmation of treatment
Name and title of the professional
Duration of treatment
Outcomes of treatment
Recommended Accommodation
b. The healthcare providers specific recommendation for accommodation(s) that directly relates to the
impairment, and is supported by functional information in the evaluation. The file is considered
incomplete if this specific recommendation is not included.
c.
If the individual did not receive any special accommodations during years of higher education, please
provide a written explanation for why accommodation is now being requested for this examination.
This should be on a separate page and attached to this form.
September 2014
Testing Center Experience Issues

All of the Academys certification exams are administered via a network of computer-based testing centers.
These centers are administered by the Academys contracted testing partner and administer a wide variety of
tests. Very rarely do any issues arise at the test center that may be perceived as having a negative effect on a
candidates performance. However, the Academy takes these issues very seriously.
In order for the Academy to be able to investigate any problems thoroughly, all issues must be reported to the
Testing Center Administrator (TCA) before leaving the test center. Issues can be reported on the exam exit
survey but must be brought to the attention of the TCA during the exam/before leaving the test center. Problems
reported later than the day of testing will not be considered.
Technical Issues
The Academy expects a candidate to be responsible for immediately notifying the proctor at the testing center
should the candidate believe there to be a technical problem with the computer or related equipment during their
exam. It may be possible for the TCA to resolve the program and restart the candidates exam or reschedule the
candidate for later the same day.
Any complaints regarding technical issues should be reported immediately and must be reported to the Testing
Center Administrator (TCA) before leaving the testing center. The candidate must also report the issue to the
Academy the same day. If it is over a weekend, a voice mail or email message must be sent to the Academy on
same day the candidate tested.
The Academy will investigate all reported technical issues and report back to the candidate within two (2) weeks
of receiving the report. Based on the results of the investigation of the reported issue, the Academy may choose
to offer a subsequent opportunity to retest.
Disruptive Issues
Candidate should expect an environment suitable to testing but should also understand that they will be testing
with other individuals who may be taking exams of varying length or requiring use of the keyboard. Noise
cancelling headphones are available to each candidate, upon request, at the testing center.
Should there be a disruption that the candidate believes is affecting his or her performance on the exam, the
situation should be reported to the TCA immediately. Should the candidate believe that his or her performance is
hindered by the disruption, the candidate may choose to end the test and inform the TCA of the reason. The
candidate must also report the issue to the Academy the same day. If it is over a weekend, a voice mail or email
message must be sent to the Academy on same day the candidate tested.
The Academy will investigate all reported disruption issues and report back to the candidate within two (2) weeks
Candidate requests for a review of the fairness or accuracy of an exam due to equipment or software failure, or
disruptive conditions in a testing center, shall result in the Academy working with its testing vendor to review
relevant incident or discrepancy reports, technical data and analyses.
Exam Content
Candidates who have an issue with a particular test question are welcome to put their concerns in writing to the
Academy. Such information will be shared with the appropriate exam committee. However, given the security of
the exam, the candidate will not receive any response regarding the content of the question, the correct answer,
or the rationale for the item.
September 2014
Candidates are permitted to appeal the appropriateness of content on the exam through its Policy on the Appeal
of Denial of Eligibility but cannot be granted access to test questions or an answer key.
Policy on Denial of Eligibility

All applicants who seek eligibility to take one of the Academys certification exams, the Certified Clinical Research
Coordinator (CCRC), Certified Clinical Research Associate (CCRA), or the Certified Physician Investigator
(CPI), must satisfy the minimum eligibility requirements as outlined in the appropriate candidate handbook for
each designation. Applicant eligibility is reviewed individually. Each applicant is automatically afforded review by
three separate reviewers, if necessary, during the eligibility review process.
Eligibility for approval to take an Academy certification exam may be denied when any part of the application
and/or disclosure statement is incomplete, illegible or does not contain the correct fees.
Eligibility for approval to take an Academy certification exam may also be denied when an application purporting
to represent and demonstrate how the applicant meets the established eligibility requirements is found to be
incomplete, and/or does not substantiate or properly demonstrate the applicants achievement of the minimum
eligibility requirements.
When any application for eligibility to take an Academy certification exam is denied, the applicant will be notified in
writing, typically via email, and given seven (7) business days to correct and submit that which is necessary to
properly complete the application process and verify minimum eligibility requirements as outlined in the
Academys certification handbooks.
If time permits and all documentation is in order, the candidates application will be processed and eligibility
granted for the examination window originally requested by the candidate. Should this process take the applicant
within three (3) business days of the start of the examination window he/she requested, the candidate will be
granted eligibility for the next available examination window.
Regardless of the items the candidate must supply, or the time line in which materials are submitted, the
candidates application may only be transferred forward to the next examination window once, based on the
examination window for which the candidate originally applied.
If the applicant cannot supply appropriate and sufficient eligibility documentation or an eligible candidate does not
take the examination by the start of the next examination window, he/she will forfeit all fees. The applicant will
need to reapply and submit all current fees in order to be consider again for eligibility.
Policy on Appeal of Denial of Eligibility

The Academy of Clinical Research Professionals (the Academy) makes every attempt to make fair and
accurate eligibility decisions based on the information provided by the applicants. An appeal procedure is
available to any applicant who has applied for certification by the Academy and who wishes to contest any
adverse decision affecting his or her application for certification status. Any individual who does not file a
request for an appeal within the required time limit shall waive the right to appeal.
3. The passing score for the exam, or the process used to establish that passing score, which may
result in failure of the certification examination.
answers. However, candidates may not have access to the test form, their answers, or the answer key.
September 2014
Appeal Process
All complete applications submitted for certification are afforded three (3) levels of review automatically, as part of
the standard review process. All applicants are selected by a reviewer, based on the first letter in the applicants
last name. Reviewers can communicate directly with applicants via email to obtain additional or clarifying
information to make an eligibility determination. If the first reviewer determines the candidate is ineligible, the
applicant will be notified by email with an explanation of the deficiency identified. The application is then
automatically forwarded to a second reviewer (except for cases of incomplete application/ documentation), based
on the first letter of the applicants last name.
The second reviewer begins review of the application in its entirety. The second reviewer can communicate
If the second reviewer determines the candidate is ineligible, the applicant will be notified by email with an
explanation of the deficiency identified. The application is then automatically forwarded to the Director of
Certification for the final level of automatic review.
The Director of Certification reviews the application in its entirety. The Director of Certification can communicate
If Director of Certification determines the candidate is ineligible, the applicant will be notified by email of the final
denial with an explanation of the deficiency identified.
Upon receipt of the notice of denial by the Director of Certification, the applicant has the option to submit a final,
written notice of appeal to the Academy no more than 7 (seven) days following receipt of notice of denial by the
Director of Certification.
In the written notice of appeal, the applicant shall submit additional, written, factual documentation to support
his/her appeal with an explanation of why he or she believes the reviewer(s) erred in his/her decision. No new
documents pertaining to the applicants eligibility shall be accepted during the appeals process. The applicant
shall bear the burden of proving the denial of eligibility was based on erroneous factual determination of the
reviewer.
The Academy Board of Trustees will review the candidates application and accompanying documents
and the appeal letter and make a determination within fifteen (15) days of receipt of the appeal. The
applicant will be notified via hard-copy mail of the decision of the Academy Board of Trustees within
seven (7) days of their vote and the decision shall be final.
Exam Appointments, Testing Experience and Exam Outcomes

Policy and Procedure on Special Accommodations
In compliance with the provisions of the Americans with Disabilities Act (1990) and Title VII of the Civil Rights Act,
as amended (42 USCG 2000e, et.seq.), the Academy of Clinical Research Professionals (ACRP) provides
qualified candidates with a disability, who supply appropriate documentation, reasonable and appropriate
accommodations in order for the candidate to take the CCRC, CCRA, or CPI exam. The Academy follows
the Principles of Fairness set forth by the Institute for Credentialing Excellence.
Under the ADA, a disability is defined as a physical or mental impairment that substantially limits one or more
major life activities. Examples of major life activities include:
Caring for ones self

Performing manual tasks
September 2014
Walking
Seeing
Breathing
Learning
Working
Qualified Candidates with a Disability

A "qualified individual with a disability" is one who has a disability and satisfies all the requisite skill, experience,
education and other requirements for certification and, with or without accommodations, can perform the essential
duties required of his/her job role. A person must be a "qualified individual with a disability" to be protected under
the ADA.
Reasonable Accommodation
Reasonable accommodations provide a candidate with a disability a fair and equal opportunity to demonstrate
his/her knowledge and skill in the essential duties being measured by the exam. Reasonable accommodations
are decided upon based on the individual's specific request, disability and documentation submitted as well as the
appropriateness of the request. Reasonable accommodations do not include steps that fundamentally alter the
purpose or nature of the exam.
Proper Documentation
The candidate must submit documentation provided by an appropriate licensed professional or certified specialist
who diagnosed the disability and is recommending reasonable accommodations. The documentation must be
submitted on the professional's letterhead. The documentation must provide a diagnosis of the disability and the
test(s) used to determine the disability. The professional must also recommend specific accommodations. These
recommendations should be based on testing that is not older than four (4) years prior to the application. The
confidentiality of all documentation submitted by the candidate is protected.
Procedure
A candidate requesting special accommodations must do so in writing by completing the Request for Special
Accommodations FormParts 1 and 2 and the request must accompany a completed application for
Certification. The request must include proper documentation from a licensed professional or certified specialist
who diagnosed the disability condition AND the specific testing aids or modifications being requested.
Accommodations, if approved, will be provided at no additional charge.
The Academy will review the request and provide a response in writing to the candidate along with his/her
eligibility determination. If the candidate has been deemed eligible to take the exam, the Eligibility Notice will
include the accommodations that have been approved.
All special accommodation forms and related documentation are confidential and will not be released without the
written consent of the candidate.
Documentation Requirements
It is the responsibility of the candidate to ensure that all required forms and supporting documentation are
submitted to the Academy. A request for special testing accommodations will not be reviewed until all
documentation is received. Required documentation includes:
A completed Request for Special Accommodations form. This form consists of two sectionsone to be
completed by the candidate, and one to be completed by the healthcare professional.
September 2014
Evaluation of the candidates disability, to be completed by the healthcare professional. Note: The
healthcare professional must be a licensed or otherwise qualified practitioner whose credentials are
appropriate to diagnose and evaluate the specific disability. Candidates requesting accommodations for
learning disorders or mental disabilities must be diagnosed by a psychiatrist, psychologist, or other
professional with a minimum of a Masters degree, with credentials recognized as competent to diagnose
a mental disorder or learning disability.
If the candidate did not receive special accommodations during his/her years of higher education, a
written explanation of why accommodations are being requested now is required. This is completed by
the healthcare professional.
September 2014

Name: ________________________________________________________________________________
Title: _________________________________________________________________________________
Organization: __________________________________________________________________________
Address: ______________________________________________________________________________
City: _________________________________ State: _________________ Zip/Postal Code: ____________
Country: ____________________________________ Phone: ___________________________________
E-mail Address: _________________________________________________________________________
Requests for Special Accommodations must be received with an application to take the examand no
less than 30 days in advance of the start of the testing window.
Please describe your disability: ____________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Date disability was diagnosed: _____________________________________________________________
Please list any previous accommodations received:
Date of
Type of Accommodation Received
Accommodation
Name of Institution / Organization

Providing Accommodation
I understand that the Academy of Clinical Research Professionals (the Academy) will use the information
obtained by this authorization to determine eligibility for a reasonable accommodation in regard to the CCRC,
CCRA, or CPI examination, by reason of my disability. I understand that the Academy reserves the right to
make additional inquiries regarding my disability and previous accommodations before making a determination as
to whether to provide the accommodations I have requested above. Under penalty of perjury, I declare that the
foregoing statements, and those in any required accompanying documents or statements, are true. I understand
that false information may be cause for denial or revocation of certification. I hereby certify that I personally
completed the above form, and that I may be asked to verify this information at any time.
I hereby authorize and request the health care professional identified below to release the information requested
by the Academy relating to my disability and the accommodation appropriate to my disability to sit for the CCRC,
CCRA, or CPI examination.
September 2014

Dear Healthcare Professional:
The individual identified above is requesting accommodation to sit for the Certified Clinical Research Coordinator
(CCRC), Certified Clinical Research Administrator (CCRA), or Certified Physician Investigator (CPI)
Examination. The Academy of Clinical Research Professionals (the Academy) policy requires that candidates
requesting special testing accommodation submit current documentation of the disability from an individual
qualified to assess the disability.
The individual listed above is requesting that you provide such documentation. The following must be completed
by you:
3) The remainder of this form (Part 2)
4) An evaluation, on professional letterhead, that includes the following information (if submitting an existing
report, it must have been written within the past 4 years):
d. Confirmation of diagnosis and functional impairment
o
Date (month/day/year) of first consultation
Date (month/day/year) the individual was last seen by you
Diagnosis, summary history, and course of the disability
Individuals current functioning and limitations in major life activities
For learning disabilities or mental disorders, the DSM classification of the diagnosis
(Diagnostic and Statistical Manual of Mental DisordersIV TR). Notes: DSM classification
does not guarantee classification as a disability under ADA, and therefore, does not
guarantee accommodation by ACRP; ACRP will not accept a diagnosis of Learning Disorder
that was made before the individual was 18 years old, if the last diagnosis date is more than
3 years old.
Diagnostic tests administered, scores, and interpretation of scores.
Confirmation of treatment
Name and title of the professional
Duration of treatment
Outcomes of treatment
Recommended Accommodation
e. The healthcare providers specific recommendation for accommodation(s) that directly relates to the
impairment, and is supported by functional information in the evaluation. The file is considered
incomplete if this specific recommendation is not included.
f.
If the individual did not receive any special accommodations during years of higher education, please
provide a written explanation for why accommodation is now being requested for this examination.
This should be on a separate page and attached to this form.
September 2014
Testing Center Experience Issues

All of the Academys certification exams are administered via a network of computer-based testing centers.
These centers are administered by the Academys contracted testing partner and administer a wide variety of
tests. Very rarely do any issues arise at the test center that may be perceived as having a negative effect on a
candidates performance. However, the Academy takes these issues very seriously.
In order for the Academy to be able to investigate any problems thoroughly, all issues must be reported to the
Testing Center Administrator (TCA) before leaving the test center. Issues can be reported on the exam exit
survey but must be brought to the attention of the TCA during the exam/before leaving the test center. Problems
reported later than the day of testing will not be considered.
Technical Issues
The Academy expects a candidate to be responsible for immediately notifying the proctor at the testing center
should the candidate believe there to be a technical problem with the computer or related equipment during their
exam. It may be possible for the TCA to resolve the program and restart the candidates exam or reschedule the
candidate for later the same day.
Any complaints regarding technical issues should be reported immediately and must be reported to the Testing
Center Administrator (TCA) before leaving the testing center. The candidate must also report the issue to the
Academy the same day. If it is over a weekend, a voice mail or email message must be sent to the Academy on
same day the candidate tested.
The Academy will investigate all reported technical issues and report back to the candidate within two (2) weeks
Disruptive Issues
Candidate should expect an environment suitable to testing but should also understand that they will be testing
with other individuals who may be taking exams of varying length or requiring use of the keyboard. Noise
cancelling headphones are available to each candidate, upon request, at the testing center.
Should there be a disruption that the candidate believes is affecting his or her performance on the exam, the
situation should be reported to the TCA immediately. Should the candidate believe that his or her performance is
hindered by the disruption, the candidate may choose to end the test and inform the TCA of the reason. The
candidate must also report the issue to the Academy the same day. If it is over a weekend, a voice mail or email
message must be sent to the Academy on same day the candidate tested.
The Academy will investigate all reported disruption issues and report back to the candidate within two (2) weeks
Candidate requests for a review of the fairness or accuracy of an exam due to equipment or software failure, or
disruptive conditions in a testing center, shall result in the Academy working with its testing vendor to review
relevant incident or discrepancy reports, technical data and analyses.
Exam Content
Candidates who have an issue with a particular test question are welcome to put their concerns in writing to the
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CRA

CRA CERTIFICATION GUIDE

Academy of Clinical Research Professionals

CCRA Exam Application Checklist

Complete the Application

Submit the Application

Welcome to the Certified Clinical Research Associate (CCRA ) Program .........................................................6

Top 10 Reasons to be a CCRA .............................................................................................................. 6

Eligibility for the CCRA Program ..........................................................................................................................9

Application for the CCRA Program .................................................................................................................... 12

Preparing for the CCRA Exam .............................................................................................................. 27

Steps to Preparing for the CCRA Exam ............................................................................................... 28

Taking the Exam .................................................................................................................................................... 30

Exam Appointments, Testing Experience and Exam Outcomes ...................................................................... 49

Certification Resources on the Web

Quick Reference Questions

Exam application received?

Didnt receive notification of eligibility

What is my Prometric testing ID

Exam rescheduling more than 29

Exam rescheduling 16 to 29 days

Prometric - $25 fee

Exam rescheduling 5 to 15 days prior

Prometric - $50 fee

No rescheduling permitted less than 5 days prior to exam date

Both: Prometric first to pay

Both: Prometric first to pay

Post Exam Questions

General Contact Information

Welcome to the Certified Clinical Research Associate (CCRA)

Top 10 Reasons to be a CCRA

About the Academy of Clinical Research Professionals

CCRC and CCRA programs received NCCA accreditation.

Certified Clinical Research Associate (CCRA) Program

From Regional to International Standards

What is Required for Certification?

Eligibility for the CCRA Program

Certification Eligibility Requirements

CRA Essential Duties

Verify Investigational Product accountability;

Conduct routine monitoring visits on behalf of the clinical trial sponsor.

CCRA Eligibility Requirements

Registered Nurse (RN)

Other, such as LPN, LVN, Medical

Bachelors degree (or higher)

High School diploma

*Clinical Research Education Programs

Be at least 216 hours in length and;

Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation

View Policy on Denial of Eligibility and Policy on Appeal of Denial of Eligibility.

Application for the CCRA Program

Have the following information ready before applying:

Application and Exam Fees

Submitting the Application

Documents Required to be Submitted WITH Application

Transfer Application to Next Exam Window

View full Policy on Transfers, Cancellation, No Shows, Refunds and Re-Examination