Progress Report: How often should the investigator submit written summaries of trial status to the IRB/IEC?

Progress Report: How often should the investigator submit written summaries of trial status to the IRB/IEC?

• A. Monthly.
• B. Every 6 months.
• C. Annually.
• D. Only at completion.

Answer: (C)

Ongoing oversight of the trial requires the IRB/IEC to receive a written summary of the trial’s status at least once a year. This annual progress report lets the IRB review how the study is progressing in terms of recruitment, retention, and data collection, and it provides a current view of safety information and any changes to the protocol or consent that might affect risk to participants. It also supports the ongoing assessment of the risk/benefit balance as the study advances. If there are significant safety concerns, protocol amendments, or other issues, the IRB can request more frequent updates or expedited reporting, but the minimum expectation is an annual status report. Monthly reports would be unnecessarily burdensome, reporting every six months is more frequent than required as a minimum, and reporting only at completion would remove the IRB’s ongoing oversight during the trial.

Ongoing oversight of the trial requires the IRB/IEC to receive a written summary of the trial’s status at least once a year. This annual progress report lets the IRB review how the study is progressing in terms of recruitment, retention, and data collection, and it provides a current view of safety information and any changes to the protocol or consent that might affect risk to participants. It also supports the ongoing assessment of the risk/benefit balance as the study advances. If there are significant safety concerns, protocol amendments, or other issues, the IRB can request more frequent updates or expedited reporting, but the minimum expectation is an annual status report. Monthly reports would be unnecessarily burdensome, reporting every six months is more frequent than required as a minimum, and reporting only at completion would remove the IRB’s ongoing oversight during the trial.