eResearch

Overview COI and CRAO Ancillary Committee members can advance a submission to the next required reviewing body prior to completing ancillary committee review by executing the Advance for IRB Review activity. This pauses the COI or CRAO committee's review and engages the IRB to begin their review of the submission. Ancillary Committee review and approval is required before the submission can be approved.

Overview When an Adverse Event (AE) is reported by the study team, IRB Staff will assign it to the appropriate reviewer(s). Once an AE is assigned to you for review, it can be found under My Reviews in the Inbox of your Home Workspace. Navigation Role: Committee Member > Home Workspace

Overview Anyone with access to a study can run an Adverse Event (AE) Summary Report or Other Reportable Information and Occurrence (ORIO) Summary Report to see how many and what types of AEs/ORIOs have occurred. Navigation Role: PI/Study Team Member > Home Workspace > Study Workspace

Overview Core Committee Staff can set the order of meeting agenda items using the Set Agenda Order activity.  Tip A best practice is to set the agenda order as late as possible prior to the meeting date so that any agenda item changes will not impact the sort order. Navigation Role: Core Committee Staff

Overview This document provides information that Ancillary Committee members can use to review submissions for human subject research in eResearch Regulatory Management (eRRM). Logging into eResearch When a new research application is submitted that requires review by your committee, you will receive an email notification. This email will have a link to the application in eResearch. Click the link to log in to eResearch. For more information, see Logging in to eResearch Regulatory Management.

The following table provides an explanation of how to interpret the possible combinations of values that can be encountered in the Appointment Selection Complete? and Student columns in Question 1.3.

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 can send the submission to a Designated Reviewer to complete the contingency review. Navigation Role: Core Committee Staff > Home Workspace

Overview When a submission (Human Subjects Application or Amendment) is assigned to be reviewed by the Cellular Therapy Ancillary Committee, the submission displays in the reviewer’s Inbox tab. The reviewer can then review or postpone the submission, which moves the submission to the reviewer’s In Progress tab. Once Cell Therapy Ancillary Committee review is complete, it displays on the reviewer’s Completed tab. Navigation Role: Cell Therapy > Home Workspace

OverviewThis document outlines the steps to view information in the Change Log (audit trail) of Reviewer Checklists.NavigationRole: Committee Member > Home Workspace > Review Workspace

Overview Any study team member who has been granted editing rights can change the Principal Investigator (PI) on a research study. However, the method for changing the PI depends on the state of the submission. If the study application is in an editable state (e.g., Pre Submission), the PI can be changed directly by editing the application. If the study application is in a non-editable state (e.g., Approved), an Amendment (AME) must be created. Navigation Role: PI/Study Team Member > Home Workspace > Study Workspace