1. “Clinical Trials Litigation” http://www.sskrplaw.com/gene/index.html. [Best single source for information regarding ongoing clinical trial lawsuits. The site contains the original pleadings/complaints for many recent research suits.] Accessed December 25, 2023.
2. “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” International Conference on Harmonization Good Clinical Practice, 1996 [Published in the Federal Register May 9, 1997 (62 F.R. 25692).
3. 21 C.F.R. Parts 50, 54, 56 (2004) [FDA regulations on conduct of clinical trials].
4. 45 C.F.R. §46.116
5. 45 C.F.R. Part 46 (2002) [DHHS regulations on conduct of human subjects research “The Common Rule”].