Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1You failed to properly obtain and document legally effective informed consent in accordance with the provisions of 21 CFR Part 50.27(a) and 21 CFR 812.100.
Passage 2You failed to ensure that the investigation was conducted in accordance with the signed agreement with the sponsor and the investigational plan. [21 CFR 812.100 and 812.110(b)].
Passage 3You failed to maintain accurate, complete, and current records relating to your participation in Study CLS-003 to 21 CFR 812.140(a)(2) and 812.140(a)(3):
Passage 4Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration. FDA has several references available at Clinical Trials and Human Subject Protection for more information on human subject protection and the conduct of clinical research.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 50.27(a)
- 21 CFR 50.25
- 21 CFR 50.27
- 21 CFR 50.20
- 21 CFR 50
- 21 CFR 812.100
- 21 CFR 812.110(b)
- 21 CFR 812.140(a)(2)
- 21 CFR 812