42 CFR Part 11

Question 1

What is 42 CFR 11?

Answer 1

Clinical Trials Registration and Results Information Submission

Question 2

Which section deals with Clinical Trials Registration?

Answer 2

42 CFR 11

Question 3

Per 42 CFR 11, where must clinical trials be registered?

Answer 3

ClinicalTrials.gov

Question 4

Per 42 CFR 11 which clinical trials must be registered?

Answer 4

Applicable clinical trials include clinical trials of FDA-regulated drug, biological, and device products and pediatric post-market surveillance studies of devices required by the FDA under the FD&C Act. The NIH also requires registration of clinical trials that receive NIH funding.

Question 5

What is the requirement, per 45 CFR 11, for reporting adverse event information?

Answer 5

Summary AE information must be reported on ClinicalTrials.gov. The number and frequency of AEs experienced by subjects must be reported in 3 tables:
- One table summarizing all SAEs
- One table summarizing other AEs with a frequency of 5% or more
- One table summarizing all-cause mortality by arm or group of the study.

All AEs must be included regardless of if they were anticipated or unanticipated