eRAM: Add Reviewer Questions

Overview

During the review process, reviewers add questions to an application in order to request clarification on or additional information about the protocol. These questions are routed through the ACUO Research Compliance Associate (RCA) where they are reviewed, summarized and then sent to the Principal Investigator (PI).

When adding questions, specify to which answer or section of the application page the question refers. Some applications, such as the Procedure page, include multiple sections and pop-up pages, making it difficult to know what is being questioned without this clarification.

After the PI responds to the questions, the application is resubmitted and routed back through the review process. Reviewers need to review the new information provided by the PI and the PI response to the questions.

Contents

Add Reviewer Notes

  1. Click the name of the application being reviewed.
  2. Click View Application.
    Notes
    • The application opens to the Principal Investigator (PI) page. You can navigate through the application by clicking Continue or selecting a page from the Jump To drop-down menu.
    • In this document, adding a reviewer question is demonstrated on the PI page. However, the process is the same regardless of the application page.
  3. Click Add.
  4. Select Draft Reviewer Question from the Type drop-down menu.
    Notes
    • This is the only option available in the Type field.
    • Draft questions are not visible to other reviewers until the review is submitted.
  5. Enter the question in the Note field.
  6. Click OK.
    Note All reviewer questions display at the top of the application page with which they’re associated. Questions can be sorted using the Filter by function.
  7. If necessary, click Add to insert another question. Repeat steps 4-5.
    Note Questions entered in error or no longer needed can be deleted by clicking Delete. On the Delete Reviewer Notes page, check the box next to the question being deleted and click Delete.
  8. To continue reviewing the application, click Jump To and select a page, or click Continue to move to the next application page.
  9. Click Exit to return to the Protocol Workspace.
  10. Click Submit Review with Questions under Activities when your review is complete.
    Note After submission, all draft review questions are published and visible to other reviewers and the RCA. Published questions can be viewed on the Reviewer Question page of the protocol workspace, or on the application pages.

Review PI Responses

  1. Click the name of the application being reviewed.
  2. Click View Differences.
  3. Select the previous version of the application that was reviewed from the Show Changes made between Current version drop-down menu.
    Note Review the PI Response and the changes made to the application data. If necessary, click the next arrow in the Differences section to expand the Differences section.
  4. If necessary, click Add in the Reviewer Question section to insert an additional question(s).
  5. Go to the next application page that contains a reviewer question and PI response by selecting the page from the Changed Steps drop-down menu.
    Note Repeat steps 4-5 until all changes have been viewed and additional questions entered.
  6. Click Close to return to the protocol page.
  7. Click one of the following under Activities:
    • Approve Without Questions if no additional questions were entered.
    • Submit Review With Questions if additional questions were added.
Last Updated: 
Wednesday, September 4, 2019