eResearch

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 a 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

OverviewThis reference document shows how to verify the status of a submitted study application and view approved documents.Home Workspace - Approved Tab

Overview The Update Common Rule Transition Status activity is used to help IRB staff track which studies are under the Pre-2018 rules vs. the Post-2018 common rule. A workspace indicator will display only for IRB staff and reviewers. If the question displays without an answer, then a determination has not been made as to whether the study should be reviewed under Pre- or Post-2018 Common Rule. If the question answer shows Yes or No, then a determination has been made.