Regulatory Management Frequently Asked Questions

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 in 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 add a new Study Team Member?

You add Study Team Members in question 1.3 of the application. See Adding a Study Team Member 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.
How do I accept my role as a Co-Investigator or Faculty Advisor on a study?

From the Need to Accept Role section of My Inbox, click the name of the application or amendment. Then, click the Accept Role activity, and answer the questions. See Accepting Your Role on the Study Team for full instructions.

What questions are asked in the study application?

There are 45 sections in the application. Not all will be required for each study. The application smart form guides you through the relevant information required for submission based on your responses to questions. See the Spreadsheet of Application Questions for a list of each question and details about data entry and/or related system logic.

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.

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

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

  • Adverse Events (AEs)
  • Other Reportable Information and Occurrences (ORIOs)
  • Scheduled Continuing Reviews
  • Amendments
Why does the Student column display on the Study Team Members table for Appointment Selection?

The Student column is displayed in the Study Team Members table and in question 1.3 to alert study team members that a member’s Student status makes appointment selection not required.

The IRB may ask a PI who shows up as a student but has a relevant appointment to select their appointment.

Note: There are situations where a student’s only appointment has nothing to do with the study, thus we cannot require an appointment for students (e.g., a biology student taking part in a human subjects research study may also be employed as a dishwasher for Facilities). However, in situations where an appointment relevant to the study is available for selection for someone marked as a “Student”, selecting an appointment is encouraged to help with reporting.
I’m not a student anymore. How can I get the student status removed?

The customer must contact the Registrar’s Office to find out how to discontinue the active student program. (Note: MCommunity profiles indicate if one has a Student affiliation.) Once the academic program is no longer active, eResearch will automatically update the person’s Student column and Organization within 48 hours of the change being entered into M-Pathways Student Administration.

My appointment information is inaccurate. How do I get it fixed?

Make sure the correct appointment is selected on the study in question. If the appointment information available for selection is inaccurate, consult your department’s HR personnel. All information relating to a person’s affiliation with the university is pulled from M-Pathways Human Resource Management System (HRMS).