Anyone with an eResearch login can create a new study application. However, ONLY the listed PI can do the initial “Submit” for an application.
The system leads study teams through a “smartform” from one system-required section to another. Always start at a system-required page (page 01 or, if you use the “Jump To:” menu, a page shown on the menu in black type rather than in gray italic type). Fill out each page as it comes to you. i.e. After filling out the study team, project summary, &c. on page 01, use the “Continue” button and let the eResearch ‘system logic’ lead you through all other system-required pages.
TIP: If you find yourself on a non-system-required page, DO NOT use the “Continue” button to leave it: in this case you may NOT be led to the next system-required page.
If you would like to make your IRB staff aware of an application before we receive it – even while it’s in Pre-Submission – you can contact us directly. IRB staff can see any pages filled out for an application at any point after the study team Creates New Study, fills out page 01, and hits “Continue” to go to page 01-1.
Every listed study team member (except “Administrative Staff”) are required to Accept Role before initial “Submit” becomes available to the PI. (One of the main reasons for this requirement is to facilitate the University tracking potential conflicts of interest.)
When the listed PI “Submits” the application, if applicable it routes first to non-IRB UM research units (including Conflict-of-Interest, Investigational Drug Service, etc.). IRB receives the application only after other required system approvals are in place.