Clinical Master Reference Guide

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 Investigation 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 (R2) Good Clinical Practice
• ICH E8 (R1) General Considerations for Clinical Studies

EU & Helsinki Directives

• Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
• European Clinical Trials Directive (536/2014)
• 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