Regulatory Management: Creating an Application for a New Study

Overview

New study applications created in eResearch Regulatory Management (eRRM) are routed to the appropriate review committee(s) upon submission, based on information entered in the application. You can start a new study application and save it for completion at a later time.

Important Information

• Any member of the Study Team can create a new study application. However, only the U-M Principal Investigator (PI) can submit a completed application. See Submit a Completed Application for more information.
• All individuals identified as a Study Team Member on the study application (except administrative staff and the PI) must accept their role before the application can be submitted. See Accepting Your Role on the Study Team for details.
• Your browser must allow cookies, Javascript, Java applets, and pop-ups for the eResearch system.

Navigation

Role: PI/Study Team Member > Home Workspace

Step-by-Step Process

Create New Application

1. Click Human Subjects Study Application under Create New to create a new study application.
2. Complete all required fields marked with a red asterisk (*).
   
3. Click Continue to save the current page and proceed to the next.
   Warning Do not use your web browser to navigate between pages. You can lose data entries when using the web browser buttons.
4. Complete the rest of the study application.

Navigating in the Application

While completing the study application, use the left navigator, and buttons at the bottom of the screen.

1. bars forms menu allows you to jump directly to any section of the application, but it ignores the smartform logic.
2. check Validate runs project validation and view a list of required pages that are not completed.
3. left Go to forms menu Shifts the focus from the smartform to the forms menu, i.e., it opens the forms menu if it was closed.​
4. print Print Print this page or this project to open a printer-friendly version.​
5. exit Exit to exit the application and return to the Study Workspace.​
6. save Save to save your changes and stay on the same page. If you attempt to exit without saving your changes, you will be prompted to save.
7. Continue right arrow to go to the next required page of the application.​

Tip It works best to use Continue to navigate through the application initially. Then select a section from the bars forms menu that you need to complete or edit. The exception is the Application Type page, where you must select a type before you can click Continue.