Overview
Once a submission has been assigned for Contingency Review, Core Staff may need to reassign the review to someone other than the originally designated reviewer. Use one of the following activities (available on submissions in the Designated Reviewer Contingency Review State) depending on your situation:
eResearch
The list below contains the acceptable file types to upload to eResearch. If you must provide documents that are in other file types, check if the document can be converted to one of the below formats before uploading.
Notes
Since all documentation is required electronically, you may occasionally need to scan documents that you receive in hard copy. Scanning locations are located throughout all campuses, and the U-M Library supports printing, scanning, and copying.
For information on purchasing a scanner, contact your department's computer administrator support.
Overview
Only the PI can submit a completed study application. Before submitting, all required fields on the application must be complete, all applicable members of the study team must accept their role, and the application must be moved to Ready-to-Submit. It is recommended that you run the Error Check and Application Checklist activities before submitting the application. For more information, see Preparing an Application for Submission.
Overview
Only the Principal Investigator (PI) can submit a completed Participating Site Application. Before submitting, all required fields on the application must be complete.
Navigation
Role: Study Team Member (PI) > My Home > Participating Site workspace
Step-by-Step Process
After clicking the name of the Participating Site from your Home Workspace, complete the following steps:
Overview
Only the Principal Investigator (PI) can submit the completed IBC Application for IBC review. Lab Personnel (e.g., Co-PI, lab manager, other lab staff) who have edit rights to the application may notify the PI that a finished application is ready for submission.
Overview
In some cases, submissions may be approved with contingencies. Prior to full approval, study teams must submit additional information to satisfy the contingencies. The study team receives a Contingencies Letter via email, which includes a link to the study. The Outstanding Issues table at the bottom of the Study Workspace lists all contingencies to be addressed. The Current State of the study is Contingencies Pending.
Overview
Reviewers may request the PI/Study Team to make changes to a submission (e.g., Study Application, Amendment, Adverse Event/Other Reportable Information and Occurrence (AE/ORIO), Continuing Review, or IBC Application). These submissions appear in the Require Action by Study Team list under the My Inbox tab of your Home Workspace.
The following procedure demonstrates submitting requested changes to Core Staff on a Study Application. The same steps apply for any reviewing body and submission type.
Overview
Termination is available for exempt studies. By submitting the Termination, the terminated application can no longer be used or modified.
Navigation
Role: PI/Study Team Member > Home Workspace
Overview
A Termination Report is used only for terminating an approved study or expanded access application upon completion of the research. Once the report is finalized, the application will be terminated and archived. Once archived, you cannot modify or use the application for research going forward.
Navigation
Role: PI/Study Team Member > Home Workspace