GMP Publications - Code of Federal Regulation Handbooks by the FDA

Clinical Master Reference Guide

GCPClinMasterRefGuide3.jpg
978-1-935131-27-4

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

  • Part 11 Electronic Records
  • Part 50 Protection of human subjects
  • Part 54 Financial disclosure by clinical investigators
  • Part 56 Institutional Review Boards
  • Part 312 Investigational New Drug Application
  • Part 314 Application to the FDA to Market a New Drug
  • Part 316 Orphan Drugs
  • Part 320 Bioavailability and bioequivalence requirements
  • Program 7348.810 - Bioresearch Monitoring Sponsors, Contract Research Organizations and Monitors
  • Program 7348.811 Bioresearch Monitoring: Clinical Investigators

US FDA Guidance Documents

  • Part 11 Scope and Application August 2003
  • Computerized Systems Used In Clinical Trials May 2007
  • Institutional Review Boards Frequently Asked Questions (FAQ)
  • Guideline for the Monitoring of Clinical Investigations
  • CGMP for Phase 1 Investigational Drugs July 2008

International Conference on Harmonisation Regulations

  • ICH E2A Clinical Safety Data Management
  • ICH E2E Pharmacovigilance Planning
  • ICH E6 (R1) Good Clinical Practice
  • ICH E8 General Considerations for Clinical Trials

EU & Helsinki Directives

  • Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
  • European Clinical Trials Directive (2001/20/EC)
  • Guidelines for good clinical practice (2005/28/EC)

GMP Publications Audit Check Lists

  • Checklist for GCP Systems Gap Analysis
  • Checklist for Computerized Systems and Part 11

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