Core Staff Review Approve with Contingencies
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- Toby Gaines
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1 Core Staff Review Approve with Contingencies Important Information In the event a submission is Approved with Contingencies, extra steps are required to complete the approval process. The basic steps to approve a study that has contingencies are:. Edit the identified issues for the submission.. Issue an Approve with Contingencies decision, which sends a letter to the study team detailing the contingencies that must be met before the research can begin.. When the study team submits the required contingencies, defer the study to the designated reviewer to review the changes.. If the contingencies have been met, use the Edit Identified Issues activity to designate that the contingencies have been completed.. Issue an Approval letter to the study team. Validate Committee Decision. Click Edit Identified Issues. Edit Identified Issues. The Edit Identified Issues form is used to Add, Change and Delete Identified Issues for the submission.. Identified Issues from the Reviewer Checklist are automatically added to the Edit Identified Issues screen. Notes: Only issues marked Publish? Yes will be published to the study team. To update an Identified Issue, click on the Description of the issue.. Click Add to create a new issue for the submission. Last updated: /0/0 of 9 v..
2 Edit Issue. Enter the Smartform Section, if desired.. Enter a Description of the issue in the field provided. Note: This field is required.. Check the checkbox if the issue Is Completed.. Use the drop-down box to choose who the issue is Assigned to.. Check the checkbox to Publish to Study Team.. Enter Reviewer Comments, if desired Click OK to save the issue or OK and Attach Another to save the current issue and create a new issue. 8 Delete Identified Issue 9 8. Check the check-box next to the issue to be deleted. 9. Click Delete. Note: The Identified Issue has been deleted from the submission. Last updated: /0/0 of 9 v..
3 Validate Committee Decision eresearch. Verify the current state is Validate Committee Decision.. Click Approve with Contingencies. Approve with Contingencies Letter. Select Reviews to Publish, if desired. Note: If this is selected, the entire Reviewer Checklist will be viewable by the Study Team.. Select the appropriate letter template from the Approval Template drop-down menu. Note: If you created a letter using the Prepare Letter step, select Saved_Application from the Approval Template drop-down menu to access the prepared letter.. Edit the letter, if necessary. Note: The list of Identified Issues that have been marked Publish to Study Team will appear.. Click OK. Note: This action sends the letter to the study team and changes the state of the submission to Contingencies Pending. Last updated: /0/0 of 9 v..
4 Core Committee Staff Home Page. Once the study team submits the requested contingencies, the submission will display in the Core Staff owner s Inbox.. Click on the Submission ID in the Inbox. Note: The state of the staff review displays Review Study Team Changes. Core Committee Staff Contingency Review. Click View Study to determine if the contingencies have been met. Note: The Change Tracking tab displays changes made to the submission.. If necessary, click Refer to Designated Reviewer. Last updated: /0/0 of 9 v..
5 7 8 Refer to Designated Reviewer eresearch. Check the checkbox next to the Reviewer needed to review the contingencies.. Select Other Reviewers to review the contingencies, if applicable. 7. Outstanding Identified Issues will also go to the assigned reviewer if they are selected. If the issue is assigned to the Primary Reviewer and you assign a Secondary Reviewer, they will not see the Outstanding Identified Issues. 8. Enter Inbox Staff Notes, if desired. 9. Click OK. Notes: This function sends the review back to the Reviewer for review of the contingencies. The Submission will remain in your Inbox until you record the contingency decision. 9 Designated Reviewer Contingency Review. Verify the current role is Designated Reviewer Contingency Review. Note: No additional actions need to be taken until the designated Reviewer submits their review.. Click My Home to return to your Inbox. Last updated: /0/0 of 9 v..
6 Core Committee Staff Inbox. After the Primary Reviewer has submitted their review, the Inbox Staff Notes displays Review from IRB Primary Reviewer Submitted.. Click on the Submission ID. 7 Designated Reviewer Contingency Review. Click on the IRB tab to verify the Primary Reviewer has reviewed the contingencies.. Verify the recommendation is Approved. Note: If the recommendation is not Approved, repeat the Approved with Contingencies process until the review determination is Approved. 7. Click Record Contingency Review Decision. Last updated: /0/0 of 9 v..
7 Record Contingency Review Decision 8. Choose the Review Determination. 9. Enter Comments, if desired. 0. Click OK Edit Identified Issue. To close out any open issues, verify the current role is Core Committee Staff Contingency Review.. Click Edit Identified Issues.. Click on the Description of the issue. Last updated: /0/0 7 of 9 v..
8 Approve. Check the box next to Is Completed?. Click OK. Approval 7 8. Click Approve to generate the Approval Letter. 7. If desired, select the Reviews to be published. Note: If this is selected, the entire Reviewer Checklist will be viewable by the study team. 8. Verify Approval Letter contents. Tip: Verify that the correct committee, correct signature and correct approval date is displayed. 9. Click OK. 9 Last updated: /0/0 8 of 9 v..
9 Post Approval Finalize Documents eresearch. Verify the current role is Approved.. Click Finalize Documents.. Select the Consent Form documents and/or Recruitment materials to finalize.. Verify dates and edit, if necessary.. Click OK to watermark the document(s) and move it to the Currently Approved Documents area under the Documents tab in the application workspace. Last updated: /0/0 9 of 9 v..
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