If Advarra needs you to expand upon or clarify information about a submission, you’ll be asked to respond to submission clarifications. You’ll receive a daily notification from CIRBI to remind you of unanswered clarifications that require your attention. Note that when a submission has unanswered clarifications, IRB review can’t proceed until you respond to them.

View All Submissions with Unanswered Clarifications

To view a list of all submissions with unanswered clarifications to which you have access, complete the following steps:

1. Navigate to the dashboard > Attention Required tab.
2. Click the Filters button.
3. In the Filters section that opens, filter Current State by the Administrative Clarifications Requested status and then click the Apply button.
4. The filtered list of results is refined to only submissions which have unanswered clarifications requiring your attention. To navigate to a submission, click its ID link.

You can follow the steps in the Respond to Unanswered Submission Clarifications topic below to respond to a submission’s unanswered clarifications.

Respond to Unanswered Submission Clarifications

From the Submission Workspace

You can view and respond to a submission’s clarifications on the Clarifications tab of the submission workspace. The counter on the tab displays the total number of clarifications on the submission (both unanswered and answered).

When an unanswered clarification is present on the submission, the orange banner is displayed to indicate how many unanswered clarifications there are, and the clarification is labeled as “Response Required.”

Responding to unanswered clarifications is a two-step process: first, you must enter answers for all unanswered clarifications. Then, when you’ve responded to all unanswered clarifications, you must submit all your answers for the IRB to review.

To view and respond to unanswered clarifications on the submission workspace, complete the following steps:

1. On the submission workspace, click the Clarifications tab to expand it. Alternatively, you can click the link in the daily clarifications reminder notification you receive to navigate to the Clarifications tab.

2. In the Clarifications tab that opens, each unanswered clarification is displayed in its own response section. For each clarification, the clarification message sent to you is displayed with the name of the submission coordinator, the date and time at which the clarification was sent, and the clarification text.

   

3. If necessary, click the Form or View Submission Form Question link on the left-hand side of the clarification to navigate to the submission form or question to which the clarification is applicable. Note that the Type field always displays IRB Clarification by default.

   

4. Beneath the clarification message, click the Add Response button to add your response to the clarification. The Add Response text field appears.

   

5. Enter your clarification response in the Add Response field.

   

   You can optionally click Add Attachment to upload a file to the clarification response. In the window that appears, drag and drop the attachment or click Browse to browse your computer for the attachment file. To finish attaching the document, click Submit Document.

6. To apply your response, click the Add button.
7. Repeat the previous steps for all unanswered clarifications listed in the Clarifications tab.

8. When you’ve finished responding to all unanswered clarifications on the submission, hover over the Submit Response box at the top of the Clarifications section and then click the Submit Response button.

   

9. In the window that appears, you can optionally attach additional documents to your overall clarification submission by clicking the Add Document button and following the attachment instructions above.
10. To finish, click OK.

From a Submission Form

You can alternatively view and respond to a clarification from the submission form to which it’s applicable if you’d like to have the context of the form in front of you while responding. To do so, complete the following steps:

1. On the submission workspace, click the Clarifications tab to expand it.
2. Click the Form or View Submission Form Question link on the left-hand side of a clarification. The form page is displayed.

   • Note that on the left-hand form menu, forms with clarifications are indicated by a comment icon. The counter on the icon indicates how many clarifications are on the form, and the orange dot indicates if they're unanswered.

     

3. On the form page, look for the form field with a comment icon. For fields with multiple sub-level records, such as research location records, multiple icons might be displayed if multiple records in the field have clarifications.

   

4. Click the comment icon on the form field. A right slider opens and displays the clarification.

5. Beneath the clarification message, click the Add Response button to add your response to the clarification. The Add Response text field appears.

   

6. Enter your clarification response in the Add Response field.

   

   You can optionally click Add Attachment to upload a file to the clarification response. In the window that appears, drag and drop the attachment or click Browse to browse your computer for the attachment file. To finish attaching the document, click Submit Document.

7. To apply your response, click the Add button.
8. Repeat the previous steps for all unanswered clarifications on all submission forms.

9. When you’ve finished responding to all unanswered clarifications, hover over the Submit Response box at the top of the Clarifications section and then click the Submit Response button.

   

10. In the window that opens, you can optionally attach additional documents to your overall clarification response by clicking the Add Document button and following the attachment instructions above.
11. To finish, click OK.

The submission transitions to the Administrative Review status after you submit your clarification responses. No further action is required from you at that time. Note that you can’t edit or delete your clarification responses after you’ve submitted them.

If you edited form fields while responding to clarifications, the Submit Clarifications activity record in the Submission History log on the submission workspace lists the forms you edited. If you attached documents to your overall clarification response in the Submit Clarifications activity, those documents are also attached to the Submit Clarifications activity record.