Food, Drug, and Cosmetic Act (FDCA): Primary federal law governing drug regulation in the US, including clinical trials of investigational drugs
21 CFR Part 11: Federal regulations governing electronic records and electronic signatures in clinical trials
21 CFR Part 50: Federal regulations on informed consent requirements for human subjects in clinical trials
21 CFR Part 54: Federal regulations requiring disclosure of financial interests by clinical investigators
21 CFR Part 56: Federal regulations governing Institutional Review Boards (IRB) operations and requirements
21 CFR Part 312: Federal regulations on Investigational New Drug (IND) Applications and clinical trial conduct
21 CFR Part 314: Federal regulations governing applications for FDA approval of new drugs
HIPAA: Health Insurance Portability and Accountability Act - Governs privacy and security of medical information
CLIA: Clinical Laboratory Improvement Amendments - Regulates laboratory testing and quality standards
NIH Guidelines: National Institutes of Health guidelines for conducting research with human subjects
Common Rule (45 CFR Part 46): Federal policy for the protection of human subjects in research
State Regulations: Various state-specific laws and regulations governing clinical trials
ICH Guidelines: International Conference on Harmonisation guidelines for conducting clinical trials
GCP Standards: Good Clinical Practice standards - International quality standards for clinical trials
ClinicalTrials.gov Requirements: Federal requirements for registration and results reporting of clinical trials
Patient Privacy Provisions: Contract sections addressing data protection and subject confidentiality
Safety Reporting Requirements: Obligations for reporting adverse events and safety concerns during trials
Intellectual Property Rights: Provisions governing ownership of trial data, inventions, and discoveries
Publication Rights: Terms governing the right to publish trial results and related research
Insurance and Indemnification: Requirements for insurance coverage and indemnification of trial participants
