Hint No. 1 — We sometimes see mention of a missing NCT number when reviewing a new submission. Please note that sometimes PIs won’t have received an NCT number from clinicaltrials.gov before the study comes to the IRB for review and approval. Therefore, any IRB request to obtain and document the NCT number should be a comment, not a contingency. A contingency requires a response before the study can be approved, whereas a note doesn’t. Because the lack of an NCT number is not relevant to our criteria for approval, the IRB can’t withhold approval based solely on the lack of an NCT number.
Hint No. 2 — Staffers listed in CLARA with only a budget administrator role are not required to complete CITI training. Because these people will not interact with human subjects or identifiable data, they do not need the usual human subject protection training.