Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to ensure that IRB-approved informed consent documents for applicable clinical trials contain the statement notifying subjects that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank may result in subjects not being provided appropriate human subject research protections or pertinent information about the clinical investigation.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 50.25(c)
- 21 CFR 50.25
- 21 CFR 56.115(a)(5)
- 21 CFR 56.108(c)
- 21 CFR 56.109(b)
- 21 CFR 56.115(a)