SOCRA CCRP Practice Exam

To whom must an investigator submit progress reports according to 21 CFR 312?

1. Sponsor only

2. IRB only

3. Both sponsor and IRB

4. The FDA

The correct answer is: Both sponsor and IRB

An investigator must submit progress reports to both the sponsor and IRB according to 21 CFR 312. This is because both parties are responsible for monitoring the ongoing progress of a clinical trial and ensuring that the rights and safety of the participants are protected. Option A is incorrect because the sponsor alone cannot overlook the progress of a trial, as they may have conflicts of interest. Option B is incorrect because the IRB alone does not have the authority to oversee the entire trial progress without the sponsor's input. Option D is incorrect because the FDA is only responsible for reviewing and approving the overall progress of the trial, not for monitoring continuous updates. Therefore, the correct option is C, as it combines both the sponsor and IRB's roles in monitoring the progress of a clinical trial.