Frequently Asked Questions

General Information

Using eResearch

Support

What is eResearch Regulatory Management (eRRM)?

The web-based eResearch Regulatory Management system centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.

eRRM helps the University better ensure that it is meeting its obligation to conduct research in an ethical manner in accordance with regulations governing research.

Who develops and maintains eRRM?

eRRM is developed under the leadership of the Office of the Vice President for Research and Information and Technology Services (ITS), with input from faculty and staff from all three U-M campuses, the institutional review boards, and other review committees.

What are the benefits of the eRRM system?

  • The Principal Investigator (PI) submits a single application that is routed automatically to required committees for review. The IRB provides the final review.
  • The study team (e.g., study coordinators, etc.) can assist the PIs in preparing applications.
  • The application "smart form" guides you through the relevant information required for submission based on your responses to questions.
  • Detailed questions and answers provide clarity/reduce ambiguity for reviewers.
  • Data is validated (at time of entry or upon submission) to ensure quality and reduce the potential for changes required after submission.
  • Reviews and approvals are conducted online.
  • Email notifications include hyperlinks to specific submissions.
  • Correspondence is maintained on the database for future reference.
  • Changes are logged and time stamped for tracking purposes.

What does a PI need to do in eRRM?

The PI on a submission is responsible for:

  • Reviewing information entered by the study team (either online or via print version)
  • Submitting the application electronically
  • Re-submitting the application if changes are required by review committees
  • Electronically submitting any adverse events, amendments, scheduled continuing reviews, and terminations.

How do I get started?

Complete the Getting Started Checklist, which includes information on the following and more:

  • Minimum system requirements
  • Obtaining a uniqname and UMICH (Kerberos) password
  • Reviewing the Pre-application Checklist

How do I add a new Study Team Member?

You add Study Team Members in question 1.3 of the application. See the Adding a Study Team procedure for instructions.

Tip: If you need to add a Study Team Member after submitting the application, use the Post Correspondence activity to ask the IRB to request changes. This will allow you to edit the application and add the team members.

What questions are asked in the new study application?

There are 45 sections in the application. Not all will be required for each study application. See the Spreadsheet of Application Questions for a list of each question and details about data entry and/or related system logic.

Required Information
1. General Study Info
2.  Sponsor Information
3. Performance Sites
4. Non-standard Applications
5. Research Design
6. Benefits and Risks
7. Special Considerations
8. Subject Detail
9. Survey/Subject Populations
10. Informed Consent
11. Confidentiality, Security and Privacy
12. Exemption
45. End of Application
Special Consideration Details
13. Subject Payments or Other Incentives
14. Health Care Treatments and Procedures
15. Drugs, Biologics, etc.
16. Devices
17. Placebo
18. Biological Specimens
19. Human Pluripotent Stem Cells
20. Genetic Analysis
21. Ionizing Radiation
22. Organ/Tissue/Cell Transfer
23. Gene Transfer
24. Secondary Data Analysis
25. Protected Health Information (HIPAA)
26. No longer in use
27. Deception or Concealment Research
28. Internet/Email
29. Survey Research
30. International
31. Watching/Listening to Audiovisual Materials
32. Data Safety Monitoring Plan
Vulnerable Subjects Details
33. Children
34. Neonates
35. Pregnant Women and/or Fetuses
36. Lactating Women
37. Women of Child Bearing Potential
38. Prisoners
39. Cognitively Impaired Adults
40. College Students (under 18)
41. Subjects Vulnerable to Coercion
MCRU and PRC
42. MCRU Information
43. MADC Information
44. Additional Supporting Documents

What is the human subjects research study review process?

When a study application is submitted, the application is reviewed first by any necessary Cancer Center personnel, then any necessary Ancillary Committees, and then by the IRB. Click the image below to open a larger version of the review process.

What if I need to record changes after a study is approved?

Once the study is approved, activities are available in the eResearch Study Workspace to submit:

  • Adverse Events (AEs)
  • Other Reportable Information and Occurrences (ORIOs)
  • Scheduled Continuing Reviews
  • Amendments

How do I accept my role as a Co-Investigator or Faculty Advisor on a study?

See the Accepting Your Role on the Study Team procedure for instructions.

What is PEERRS Human Subjects Certification?

Investigators, Co-Investigators, Faculty Advisors and Study Coordinators/Project Managers are required to complete one of two PEERRS Human Subjects training modules for a study application to be approved:

  • Human Subjects - Biomedical & Health Sciences
  • Human Subjects - Social & Behavioral Sciences
eRRM displays that status of your PEERRS certification in the study application.

Tips:

  • Allow up to 48 hours for PEERRS information to appear in eRRM if you recently completed your certification or were added as a new user to eRRM.

  • Non-U-M collaborators listed as study team members on a research project initiated at U-M must demonstrate completion of human subject training. See the PEERRS website for details.

  • For instructions on how to register for PEERRS training, see the PEERRS website.

Where can I get help with using eRRM?

  • For questions related to application content or about how to answer a submission question, contact your IRB office or IBC office.
  • For help using eRRM (e.g., navigation, connectivity or technical issues), contact the ITS Service Center.
  • To propose system changes or new functionality, see the Contact Us page.

Where can I get training for using eResearch?

See the eRRM Training page for information about training sessions, to obtain step-by-step procedures, and other materials.

To become familiar with and practice working in eRRM, visit the Sandbox.

What browser/operating system do we need for using eResearch?

See the ITS System Requirements page for more information.

How do I change my UMICH (Kerberos) password?

See the ITCS Choosing and Changing a Secure UMICH password page for information on changing your UMICH Kerberos password.