Regulatory Info – USA

21 CFR, Part 11
CFR: Electronic Records; Electronic Signatures
21 CRF, Part 50
Protection of Human Subjects
ICH, Document E6
Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance ICH
Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
Information Sheet Guidance
Investigator Responsibilities
Protecting the Rights, Safety, and Welfare of Study Subjects
Guidance for Industry Adaptive Design Clinical Trials
Drugs and Biologics DRAFT GUIDANCE
FDA Guidance: Risk Based Monitoring