Introducing OpenClinica

Its all about data

Subject Diary CRF DCF Investigator Sample Monitor CRF DCF Statistician NDA

Lab Results

Clinical Data

Regulatory Authority

Involved Laboratories

Data Manager

Clinician

What is CDMS?
A clinical data management system or CDMS is used in clinical research to manage the data of a clinical trial It is set up to help with processing data from source through validation checks, analysis, reporting and storage; Also useful for Coding (particularly for AEs and Medications)
MEDRA (Medical Dictionary for Regulatory Activities) WHOART (WHO Adverse Reactions Terminology)

Institutional Approach
Setting up a specific CDMS requires institutional decision making at policy level Whatever the choice, it comes with a cost Requires infrastructure and equipment set up Requires minimum core competencies Dedicated time for learning and development Opportunities to try out

Preferred Software characteristics

Standards based Well known many skilled practitioners available Readily mastered and modified Should run on any platform Should be affordable for small groups in resource constrained countries

Why an open source approach?

Potential advantages of Open Source solution
Cheaper More amenable to change No vendor lock in More able to be integrated with other systems Likely to be well documented Designed to be multilingual Open source software works eg R, Apache, MySQL Used by major IT players eg Google, HP & IBM Has been argued provides better software
saved the Human Genome Project according to Lincoln Stein

Introducing OpenClinica
Free, open source, web-based software for EDC built by Akaza Research

Features:
Management of diverse clinical studies through a unified interface Clinical data entry and validation Data extraction Study oversight, auditing, and reporting

Creating Data Bases in OpenClinica

Designing a database in OC; requirement and flow of data.
Submit data Module; Webbased Data entry and validation

Clinical Case Report Forms (CRF)

OC - DataBase

Define CRFs in Excel Temp.

CRF Design, validation and import

Data Base Creating in OpenClinica

A part of CRF Excel Template: Some tricks.
Resp_Type
Item_name ons Resp_Valu es Date type Resp_Lab el Resp_opti Validation Required 1 1 1 Page no 1 Col_No 1 Label Units

childini

Child Initials

text

ST

regexp: /[AZ]{3}/ regexp: /[0-9, A-Z]{7}/ func: gte(-3.0)

pidnu

PAD No.

text

ST

WHZsco Wght/hght Z re score

text

REAL

Creating Databases in OpenClinica

Defining CRF on Excel Template ITEM_NAME - This is the unique label or variable name for this data element. DESCRIPTION_LABEL - give an explanation of the data element and the value(s) it captures. UNITS - the units that the value of this data element should be captured in. GROUP_LABEL - grouped items will display as a row within a table. COLUMN_NUMBER - allow adjacent items or items with the same parent to be aligned together. RESPONSE_OPTIONS_TEXT - list of the text values of the responses for this response set as a comma-delimited string. RESPONSE_VALUES_OR_CALCULATIONS - comma-delimited list of the encoded values. DATA_TYPE - data type; ST, INT, REAL, DATE. VALIDATION - validation expression to run an edit check on this item VALIDATION Expression - Expression Type: 1) regexp - Supports Java-style regular expressions. regexp: /regular expression/ e.g regexp: /[A-Z]{3}/, requires a three-letter string (all uppercase) 2) func - Supports built-in library of basic integer functions. func: func(args) e.g func: range(1, 10), func: eq(1), func: gte(10.5) etc.

The Back End of OpenClinica

Developed using Java J2EE framework Application Server- Tomcat 5.x Uses JDBC with JSP based front-end.

Database PostgreSQL 8.x or Oracle 10g

custom ports to DB2, SQL Server, or MySQL also possible Has 74 related tables

Important Features of OpenClinica

Organization of clinical research by study protocol and site.

Dynamic generation of web-based CRFs in portable Excel templates.

Management of longitudinal data for recurring patient visits Data import/export tools for migration of clinical datasets.

Interfaces for data query and retrieval across subjects, time, and clinical
parameters Compliance with regulatory guidelines e.g. 21 CFR Part 11 Built on robust and scalable technology infrastructure interoperable with relational databases

Designing CRFs
Done in excel using a blank CRF template provided by Openclinica

Uploading CRFs
The excel sheet is then uploaded onto OpenClinica

Event Definition

Data Entry

Data Extraction

System End of OpenClinica

The Back Up Setting

Database server Database
NAS1

PgDump utility Creates a backup file on the secondary HDD on the main server. File automatically copied to NAS1

Backups implemented via a scheduled command running as a batch file that writes out the data and metadata for each of the studies databases adding Timestamp information to the filename.

Restore Process
Installing Application Stack I.E. Postgresql, Apache Jarkata Tomcat,J2SE runtime environment and Deploying OpenClinica Using a suitable Postgres database GUI(e.g. pgadmin III) create a new blank database on the database server Run the pg_restore command on the server and select the backup file to restore

Deploying O/C for Multiple Sites

OC is deployed a as Openclinica.war file Web Application archive. It is a JAR(JAVA ARCHIVE) file used to distribute a collection of Java
Server Pages, servlets, Java classes, XML files, tag libraries and static Web pages (HTML and related files) that together constitute a Web application.

Standard Installation Process is well documented inside an instructions file that ships with the application. To deploy separate instances, rename the Openclinica.war to [studyname].war Deploy as a normal OC application using the standard procedure and effect changes in database credentials inside the datainfo.properties of the deployed web Application.

Working with OpenClinica

Policy determination needed Required human and material resources allocated When know-how is established, utilization requires only 5 main steps:
Designing Creating CRFs Event definitions Data Entry Data Extraction

GCP Regulations and OpenClinica

O/C by design, is compliant to the most stringent regulatory requirements O/C is designed to be compliant to FDA 21 CFR Part 11Electronic Records; Electronic Signatures These are guidelines that govern the use of electronic records and signatures ; and can be summarized in two broad categories:
Technology best practice Policy and procedures best practice

Technology Best Practices

Audit trail must be independently generated Ensure that system maintains a irrefutable link between documents, metadata and the electronic signature. Establish clear electronic signature manifestations for all electronic records. Validate the system. Establish role-based access and control. Establish password and identification controls. Series of signings. Avoid hybrid systems, where practical.

Do not over customize technology solutions.

Policy & Procedures Best Practices

Establish corporate internal policies and guidelines for:
Validation and procedures Disaster recovery Revision and change control procedures System access and security procedures Training procedures Document control procedures

Develop a clear, comprehensive migration strategy. Understand the impact of open or closed system definitions. Establish retention policies based on current predicate rule requirements.