Delinquent Progress Reports

WCG IRB will continue to follow-up with the investigators, sponsors and CRO contacts to facilitate timely receipt of a continuing review reports. If a completed form is not received by the due date, approximately 10 days after the due date, a “past due” notification is sent.

The Board may take action to suspend or terminate approval of research if reports are not accurately completed and returned promptly. If WCG IRB suspends or terminates the study, at a minimum, the investigator and sponsor will be notified of the Board’s action.

If the Board suspends the research, WCG IRB is required to report the suspension to the appropriate federal agency or agencies (for example, FDA and/or OHRP)  If the suspended investigator is at an institution which has notified WCG IRB that they will self-report these actions to the appropriate agency or agencies, the institution will receive a notification of the Board’s action and a cover letter reminding them of the reporting requirement. The institution has 30 days to then report to the agency and copy WCG IRB.