Overview
Study Team Members and Core Committee Staff can use the Create Participating Site Application activity from the Multi-Site (parent) Study workspace to create a project application for external sites with University of Michigan as the IRB of record.
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Role: PI/Study Team Member or Core Committee Staff > My Home > Study workspace
eResearch
Overview
Study teams receive an email reminder that their research application is due for a Scheduled Continuing Review (SCR) 30, 60, and 90 days prior to the study expiration date. Create an SCR to renew or terminate your study.
Navigation
Role: PI/Study Team Member > Home Workspace
Overview
Study teams are required to submit Adverse Events (AEs) and Other Reportable Information and Occurrences (ORIOs) via eResearch Regulatory Management (eRRM). AE/ORIO reports can also be created to follow-up on previously reported AEs/ORIOs.
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
Overview
If a submission was approved with contingencies, and the contingencies addressed by the Study Team require a review by the committee members prior to final approval, then IRB Staff will send the submission to a Designated Reviewer(s) to complete the contingency review.
Designated Reviewers asked to review a submission will be notified via email. Reviewers should access eRRM submissions assigned to them via the email link (e.g. REV00123456).
Overview
Opening an SSRS report in Excel allows users the ability to customize and manipulate data to meet their needs (e.g., perform additional calculations; remove unneeded rows/columns, etc.). In order for an SSRS Report to display correctly in Excel, it must be exported as a .CSV file (comma separated values).
Overview
Use the Fast Find method instead of searching through or filtering All Submissions to find a particular study. Viewing All Submissions creates a processing load on the system that could cause overall system slowness.
Navigation
Role: Core Committee Staff > Home Workspace
There is a 268 Megabytes limit per file uploaded. Any file (such as a scanned document) larger than 268 MB will not be uploaded to eResearch. You will receive an error if you attempt to upload a file larger than 268 MB.
Filtering allows you to narrow the list of choices and results in many areas of the eResearch system. For example, if you are looking for a particular study in your Home Workspace, you can filter the list of applications to make it easier to locate that study.
Within an application, you can select different Filter by values, such as First Name, Last Name, ID, Organization, and more.
Overview
Except for those with the role of Principal Investigator or Administrative Staff, study team members who are not affiliated with U-M (e.g., individuals with a Friend or Sponsored account) must access eResearch Regulatory Management and accept their role before an application can be submitted. This process allows the individual to verify and accept their role on the study team and to maintain compliance with U-M Conflict of Interest policies.