Overview Incident Reports are the equivalent of the AE/ORIO submission for a HUM application. An Incident Report is submitted when a significant incident occurs that requires acknowledgement by the IRB. An Incident Report (IR) can be created by repository personnel with edit rights listed on the approved application, but only the repository director can submit it for review. After submission, the IR is locked and no further changes can be made unless requested by a reviewer.
Overview A Termination Report is submitted only if all activity governed by the repository’s procedures will end permanently. A Termination Report can be created by repository personnel with edit rights listed on the approved application, but only the repository director can submit it for review. After submission, the Termination Report is locked and no further changes can be made unless requested by a reviewer. Only one Termination Report or Continuing Review submission for a Repository Application can be in progress at a time.
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. Navigation Role: PI/Study Team Member or Core Committee Staff > My Home > Study workspace
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 MB 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. To verify the file size: