Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?
IRBs are required to function under written procedures. One of these procedural requirements [21 CFR 56.108(a)(3)] requires ensuring “prompt reporting to the IRB of changes in a research activity.” The completion of the study is a change in activity and should be reported to the IRB. Although subjects will no longer be “at risk” under the study, a final report/notice to the IRB allows it to close its files as well as providing information that may be used by the IRB in the evaluation and approval of related studies.
Related Questions
- Im a sponsor: I think investigators and monitors/CRAs will need a user manual to use Hypernet for a clinical study. Do you provide user manuals and/or training?
- May an IRB require that the sponsor of the study and/or the clinical investigator be identified on the studys consent document?
- Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?
