Planned Administrative Withdrawal of Applications by IRBMED
An IRB application is considered “abandoned” by IRBMED when the application has been with the study team for more than 6 months without the study team addressing the changes required for approval. This applies to new study applications (HUMs) as well as child submissions (AME, SCRs, and ADVs). Addressing these large volumes of “abandoned” studies that do not have an appropriate state of closure is important as we start planning toward transition to the new eResearch application in the coming years.
This announcement describes IRBMED’s action plan to manage these abandoned IRB applications, beginning on March 2, 2020.
- New study applications or Amendments that have been pending since 2018 or earlier years, will be withdrawn in the eResearch system through the “Administrative Withdrawal” activity without prior individual notice to study teams. After this action is completed, study team members will be notified of the action through an automated correspondence in eResearch. After an application is withdrawn, it is archived and no longer able to be submitted; however, study teams will be able to access information from the IRB application at any time.
- For new study applications or Amendments pending from January 2019 to September 2019, the study team will be contacted in eResearch for a status update. If there is no response from the study team by the timeframe specified in the correspondence, these applications will also be administratively withdrawn by IRBMED. After an application is withdrawn, it is archived and no longer able to be submitted; however, study teams will be able to access information from the IRB application at any time.
- For Continuing Reviews or ADV (AE/ORIO) submissions, irrespective of the timeframe, the study team will be contacted in eResearch for a status update.
Contact IRBMED with any questions or concerns.
email@example.com or 734-763-4768