Family Health International 2009

1
Guidelines and Requirements
Guidelines and Requirements
Local Reg.
45 CFR 46
21 CFR 312
21 CFR 56
21 CFR 54
21 CFR 50
21 CFR 11
ICH GCP E6
Guidelines&
Requirements
An international ethical and scientific quality
standard for designing, conducting, recording
and reporting trials that involve the participation
of human subjects.
1. GLOSSARY
2. THE PRINCIPLES OF ICH GCP
3. IRB/IEC
4. INVESTIGATOR
5. SPONSOR
6. CLINICAL TRIAL PROTOCOL
7. INVESTIGATORS BROCHURE
8. ESSENTIAL DOCUMENTS
Family Health International 2009
2
Guidelines and Requirements
Guidelines and Requirements
Local Reg.
45 CFR 46
21 CFR 312
21 CFR 56
21 CFR 54
21 CFR 50
21 CFR 11
ICH GCP E6
Guidelines&
Requirements
Guidelines on electronic records and electronic
signatures
Defines the criteria under which electronic records
and electronic signatures are considered to be
trustworthy, reliable and equivalent to paper records.
Subpart A General Provisions
Scope
Implementation
Definitions
Subpart B Electronic Records
Controls for closed systems
Controls for open systems
Signature manifestations
Signature/record linking
Subpart C Electronic Signatures
General requirements
Electronic signatures and controls
Controls for identification codes/passwords
Family Health International 2009
3
Guidelines and Requirements
Guidelines and Requirements
Local Reg.
45 CFR 46
21 CFR 312
21 CFR 56
21 CFR 54
21 CFR 50
21 CFR 11
ICH GCP E6
Guidelines&
Requirements
Guidelines on Protection of human subjects
in clinical trials
To protect the rights and safety of subjects
involved in an investigational trial
Subpart A--General Provisions
Subpart B--Informed Consent of Human
Subjects
Subpart C [Reserved]
Subpart D--Additional Safeguards for Children
in Clinical Investigations
Family Health International 2009
4
Guidelines and Requirements
Guidelines and Requirements
Local Reg.
45 CFR 46
21 CFR 312
21 CFR 56
21 CFR 54
21 CFR 50
21 CFR 11
ICH GCP E6
Guidelines&
Requirements
Guidelines on Financial Disclosure by
Clinical Investigators
To minimize a potential source of bias in
clinical studies due to a financial interest
54.1 - Purpose.
54.2 - Definitions.
54.3 - Scope.
54.4 - Certification and disclosure
requirements.
54.5 - Agency evaluation of financial
interests.
54.6 - Recordkeeping and record retention.
Family Health International 2009
5
Guidelines and Requirements
Guidelines and Requirements
Local Reg.
45 CFR 46
21 CFR 312
21 CFR 56
21 CFR 54
21 CFR 50
21 CFR 11
ICH GCP E6
Guidelines&
Requirements
Guidelines on Institutional Review Board
To set general standards for the composition, operation and
responsibility of an IRB that reviews clinical investigations
regulated by the FDA
Subpart A--General Provisions
Subpart B--Organization and Personnel
Subpart C--IRB Functions and Operations
Subpart D--Records and Reports
Subpart E--Administrative Actions for Noncompliance
Family Health International 2009
6
Guidelines and Requirements
Guidelines and Requirements
Local Reg.
45 CFR 46
21 CFR 312
21 CFR 56
21 CFR 54
21 CFR 50
21 CFR 11
ICH GCP E6
Guidelines&
Requirements
Guidelines on Investigational New Drug Application
To set procedures and requirements governing the
use of investigational new drugs, including
procedures and requirements for the submission to,
and review by, the FDA of IND
Subpart A--General Provisions
Subpart B--Investigational New Drug Application (IND)
Subpart C--Administrative Actions
Subpart D--Responsibilities of Sponsors and
Investigators
Subpart E--Drugs Intended to Treat Life-threatening
and Severely-debilitating Illnesses
Subpart F--Miscellaneous
Subpart G--Drugs for Investigational Use in Laboratory
Research Animals or In Vitro Tests
Family Health International 2009
7
Guidelines and Requirements
Guidelines and Requirements
Local Reg.
45 CFR 46
21 CFR 312
21 CFR 56
21 CFR 54
21 CFR 50
21 CFR 11
ICH GCP E6
Guidelines&
Requirements
Guidelines on Protection of Human Subjects
To Establishes the DHHS requirements for the independent
review of research by an IRB and informed consent of study
subjects.
Applies to clinical studies conducted with funding from any
US federal agency.
Subpart A Basic HHS Policy for Protection of Human
Research Subjects
Subpart B Additional Protections for Pregnant Women,
Human Fetuses and Neonates Involved in
Research
Subpart C Additional Protections Pertaining to Biomedical
and Behavioral Research Involving Prisoners as
Subjects
Subpart D Additional Protections for Children Involved as
Subjects in Research