Selected regulations and guidance for drug studies as of April 1, 2004 (Clinical Research Resources, 2004)
CFR Title 21, Food & Drugs: Index to Part 11, 50, 54, 56, 312, 314: 11. Electronic records; electronic signatures -- 50. Protection of human subjects -- 54. Financial disclosure by clinical investigators -- 56. Institutional review boards -- 312. Investigational new drug application -- 314. Applications for FDA approval to market a new drug -- Proposed Amendments: 312.32. IND safety report -- 312.64. Invesigator reports -- ICH guidelines (Step 5, US: E6. Good clinical practice: consolidated guidance -- E2A. Clinical safety data management: definitions and standards for expedited reporting -- E8. General considerations for clinical trials -- European directive on GCP 2001/20/EC -- Additional guidance: Guideline for monitoring of clinical investigations -- Selected drug development Wen sites -- PhRMA principles on conduct of clinical trials -- Compliance manual for FDA staff (#7348.810)