Considering investing in clinical trial participation only requires a broad understanding of the domain, roles, and requirements. Actually getting started is another level of effort, and the specifics begin to matter far too much for a guide like this to be useful to any given AIC operator. Here are all the resources linked in this guide, plus many other helpful links to vendors, site networks, events, and organizations in the space.
Appendix
Further reading and resources
Published: 2025-12-11
Regulatory, compliance, and legal resources
- clinicaltrials.gov
- “Development & Approval Process” from CDER
- Center for Drug Evaluation and Research (CDER) homepage
- Center for Biologics Evaluation and Research (CBER) homepage
- National Institutes of Health (NIH) website
- FDA IRB (Institutional Review Board) FAQ
- Code of Federal Regulations
- Federal Register
- FDA Clinical Trial Forms
Good Clinical Practice resources
- FDA’s Good Clinical Practice page
- ICH GCP E6(R3), Jan 6 2025
- CITI Program’s GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course
- Department of Health & Human Services’ Common Rule page
- Free (non-drug-related) GCP course
- FDA ICH Guidance Documents
- WMA Declaration of Helsinki