eResearch

Regulatory Management: Creating an Adverse Event/ORIO

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.

Regulatory Management: Creating an Application for a New Study

OverviewNew 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

Regulatory Management: Designated Reviewer - Contingency Review

OverviewIf 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 eResearch Regulatory Management (eRRM) submissions assigned to them via the email link (e.g. REV00123456).

Regulatory Management: Export SSRS Report to Excel Spreadsheet

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).

Regulatory Management: Fast Find

OverviewUse 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.NavigationRole: Core Committee Staff > Home Workspace

Regulatory Management: File Size Limits

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.

Regulatory Management: Filtering

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 on 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.

Regulatory Management: Friend Account – Accepting Your Role on the Study Team

OverviewExcept 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 Account or Sponsored account) must access eResearch Regulatory Management and accept their role before an application can be submitted.

Regulatory Management: History Rollback for Uploaded Documents

Overview In most instances, when uploading/attaching a file in a section of the Human Subjects Research application (HUM), you have the ability to upload revised versions of the file as needed. If you’ve uploaded multiple versions of a file and wish to revert back to a previously uploaded version, you can do so using the History & Rollback function. Navigation Role: All Roles > Home Workspace > HUM Application > Document location

Regulatory Management: Human Subjects Application Review Process - Roll Back FAQs

Overview A roll back is when an eResearch Human Subjects submission is manually moved to a different state in the review process.