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The 600+ page GCP Master Handbook is a complete reference
library for the clinical professional. This handbook
comes in a easy to carry 4.5" x 7.5" pocket size booklet for
quick access to standards and references.
Includes:
US FDA Title 21 CFR Parts
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Part 11 Electronic Records
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Part 50
Protection of human subjects
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Part 54
Financial disclosure by clinical investigators
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Part 56
Institutional Review Boards
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Part 312 Investigational New Drug Application
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Part 314 Application to the FDA to Market a New Drug
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Part 316 Orphan Drugs
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Part 320 Bioavailability and
bioequivalence requirements
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Program 7348.810 - Bioresearch
Monitoring Sponsors, Contract Research Organizations and
Monitors
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Program 7348.811 Bioresearch
Monitoring: Clinical Investigators
US FDA Guidance Documents
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Part 11
Scope
and Application August 2003
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Computerized Systems Used In Clinical Trials May 2007
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Institutional Review Boards
Frequently Asked Questions (FAQ)
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Guideline for the Monitoring of
Clinical Investigations
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CGMP
for Phase 1 Investigational Drugs July 2008
International Conference on Harmonisation Regulations
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ICH E2A Good Clinical Practice
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ICH E2E Pharmacovigilance
Planning
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ICH E6 (R1) Clinical Safety Data Management
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ICH E8
General Considerations for Clinical Trials
EU & Helsinki Directives
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Declaration of Helsinki - Ethical Principles for Medical
Research
Involving Human Subjects
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European Clinical Trials Directive (2001/20/EC)
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Guidelines for good clinical practice (2005/28/EC)
GMP
Publications
Audit Check Lists
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