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ICH E6(R3) Good Clinical Practice
Part 50 - Protection of Human Subjects
The GMP 210/211 regulations address issues including recordkeeping
International GMP Master Guide
Master GMP Trainer - US FDA Title 21 CFR Parts:
Clinical Master Reference Guide 210 ICH E6(R3) Good Clinical PracticeThe 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
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