21 CFR Part 11: Federal regulation governing electronic records and electronic signatures in clinical trials, ensuring their trustworthiness, reliability, and equivalence to paper records
21 CFR Part 50: Federal regulation for the protection of human subjects in clinical trials, including informed consent requirements and safeguards for subject safety
21 CFR Part 54: Federal regulation requiring disclosure of financial interests by clinical investigators to ensure study integrity and prevent bias
21 CFR Part 56: Federal regulation governing Institutional Review Boards (IRBs), their composition, functions, operations, and responsibilities
21 CFR Part 312: Federal regulation concerning Investigational New Drug Applications, governing the conduct of clinical trials for investigational drugs
45 CFR Part 46: The 'Common Rule' - federal policy for the protection of human subjects in research conducted or supported by federal departments
HIPAA: Health Insurance Portability and Accountability Act - federal law protecting patient privacy and securing health information
Food, Drug, and Cosmetic Act: Primary federal law governing food and drug safety, including requirements for clinical trials and drug approval
Clinical Laboratory Improvement Amendments (CLIA): Federal standards for laboratory testing and quality assurance for clinical trial laboratories
Federal Anti-Kickback Statute: Law prohibiting the exchange of anything of value to induce or reward referrals of federal healthcare program business
False Claims Act: Federal law imposing liability on persons/companies who defraud governmental programs, including clinical research funding
Stark Law: Law prohibiting physician self-referral for certain designated health services payable by Medicare/Medicaid
ICH-GCP Guidelines: International Conference on Harmonisation - Good Clinical Practice guidelines providing international ethical and scientific quality standards
Declaration of Helsinki: International ethical principles for medical research involving human subjects
EU GDPR: European Union General Data Protection Regulation - comprehensive data protection law affecting international clinical trials
State Medical Practice Acts: State-specific laws governing medical practice, including requirements for clinical research conduct
Patent Laws: Federal and state laws governing intellectual property rights for inventions and discoveries from clinical research
Medicare/Medicaid Billing Rules: Federal requirements for billing and reimbursement related to clinical trial services
IRB Requirements: Institutional Review Board specific requirements for protecting human subjects and ensuring ethical conduct of research
Trade Secret Protection: Laws protecting confidential business information and proprietary research data in clinical trials
