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.
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.
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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.
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Role: Cell Therapy > Home Workspace
Overview
This document outlines the steps to view information in the Change Log (audit trail) of Reviewer Checklists.
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Role: 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.
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Role: PI/Study Team Member > Home Workspace > Study Workspace
Overview
This procedure covers how to request application changes and communicate with study team, core staff, and reviewers.
There are multiple methods for Core Committee Staff to communicate with study teams, including requesting changes to the submission, sending correspondence, and adding comments directly to the submission. All change requests, correspondence, and comments are tracked in the eResearch Regulatory Management (eRRM) system for future reference.
Overview
Important Information
The option to clone an application is only available for Cancer Center studies. All documents attached to the original submission will be removed from the cloned application. Cloned applications are saved in the Pre Submission State.
The Study Coordinator will receive an email notification with the ID of the newly created application. If a Study Coordinator is not assigned to the application, the notification will be routed to the PI. This process may take several minutes.
A Conflict of Interest (COI) section appears in the following activities for a human subjects study application (HUM) or an amendment (AME): Accept Role, Submit Application, and Submit Amendment. In 2014, the COI section changed to:
Overview
IBC Applications assigned to a committee reviewer display in the IBC Applications Requiring Review list on the Inbox tab of the Committee Member Workspace. This document covers how to:
Locate IBC Applications for Review
View an IBC Application (View Project, View Differences, Application Summary)
Submit Review
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Role: Committee Member > Home Workspace