Académique Documents
Professionnel Documents
Culture Documents
The Essentials of
Good Clinical Practice (GCP)
2
Objectives (Continued)
3
Good Clinical Practice
4
Elements of
Good Clinical Practice
Federal Regulations
Other government
The letter of the law
regulations
Regulatory Agency
State and local laws
Guidelines
Sponsor, site,
ICH GCP Guidelines
ERC/EC/IRB, SOPs
The spirit of the law
Practice Acts and
Licensure
Standards of Care
5
Relationship Between GCP Elements
6
ICH (International Conference on
Harmonization) GCP Guidelines
7
ICH GCP Guidelines
8
Objectives of the
ICH GCP Guidelines
9
Organization of ICH GCP Guidelines
1) Glossary of Terms
2) The Principles of ICH GCP
3) Institutional Review Board (IRB), or
Independent Ethics Committee (IEC)
4) The Investigator
5) The Sponsor
6) Clinical Trial Protocol and Protocol Amendments
7) The Investigators Brochure
8) Essential Documents for the Conduct of a Clinical Trial
10
Organization of ICH GCP Guidelines
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The Principles of ICH GCP
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The Principles of ICH GCP (Cont.)
13
The Principles of ICH GCP (Cont.)
14
The Principles of ICH GCP (Cont.)
15
3.1 - 3.4 ICH GCP and the IRB
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4.1 - 4.13 ICH GCP and the Investigator
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4.1 - 4.13 ICH GCP and the Investigator (Cont.)
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Examples of GCP at the Site
Investigator responsibilities
Consent responsibilities
IRB responsibilities
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Examples of GCP at the Site (Cont.)
Protocol responsibilities
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5.1 - 5.23 ICH GCP and the Sponsor
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6.1 - 6.6 ICH GCP and Trial Protocols
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7.1 - 7.5 Investigators Brochure
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The Essentials of Good Clinical Practice
24
FDA GCP Inspections
CDER: 354
1. Protocol violations
2. Recordkeeping failures
3. AE reporting failures
4. Informed consent violations
5. Drug accountability failures
CBER: 109
CDRH: 183
25
SOPs
26
The
AnEssentials
Introduction
of Good
to Clinical
Clinical
Research
Practice
Questions?
Thank you!
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