Module 6: Validating Decisions
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1 Table of Contents Module 6: Validating Decisions Module 6 Objective: Covers how Core Staff members process the decisions of the reviewers on each eresearch submission through a decision validation. Refer to the table of contents below for the topics covered in Module 6. Table of Contents Validating Decisions Overview... Preparing Letters Prior to Validating Review Decisions (Optional Step)... Approve... 4 Approve with Contingencies... 5 STEP Edit Contingencies... 5 STEP Send Approve with Contingencies Letter... 6 STEP Refer to Reviewer... 7 STEP 4 Enter Completion Date for Contingencies... 8 STEP 5 Issue Approval Letter... 9 Disapprove... 0 Action Deferred... Tabled... Finalizing Documents... Last updated: 0//07 of 4 v..6
2 Validating Decisions Overview Validating Decisions Overview Core Staff members are responsible for processing the decisions of the reviewers on each eresearch submission. This is done through a decision validation. Validate Decision A validation activity is provided for each decision type, which changes the state of the submission to reflect the decision. Some decisions send a letter to the study team. The possible decision types include: o o o Approve The Approval letter is sent to the study team. It includes the approval date and the expiration date. (See page 4) Approve with Contingencies The Approved with Contingencies letter is sent to the study team. This letter contains the contingencies that must be completed before the study team can begin their research. (See page 5) Disapprove The Disapproved letter is sent to the study team, informing them that the IRB has not approved the study. (See page 0) o Action Deferred No letter is sent to the study team. (See page ) o Table No letter is sent to the study team. (See page ) o You can prepare the letter to be sent to the study before you complete the Validate Decision activity. This letter can be saved for use during the Validate Decision activity. See page for more information. Last updated: 0//07 of 4 v..6
3 Preparing Letters Prior to Validating Review Decisions Preparing Letters Prior to Validating Review Decisions (Optional Step) Important Information Letter templates are provided in eresearch for communicating various decisions to the study team. These templates can be edited during the Validate Decision step. If extensive edits to the letter template are required, the Core Staff may use the Prepare Letter step to complete the edits prior to validating the decision.. From the Study Workspace, click Prepare Letter. Prepare Letter Window. Select the appropriate Approval Template from the drop-down menu.. Click the down arrow to open the template editor toolbar. 4. Edit the letter. 5. Click OK. Note: This action does not send the letter to the study team. 4 5 Last updated: 0//07 of 4 v..6
4 Approve Approve. Click Approve. Approve Window. 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. 4. Click OK. Note: This action sends the letter to the study team and changes the state of the submission to Approved. 4 Last updated: 0//07 4 of 4 v..6
5 Approve with Contingencies Important Information Approve with Contingencies 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 contingencies 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. 4. If the contingencies have been met, use the Edit Open Issues activity to enter a completion date for the contingencies. 5. Issue an Approval letter to the study team. STEP Edit Contingencies. Select Edit Open Issues. Last updated: 0//07 5 of 4 v..6
6 Edit Contingencies Edit Window eresearch Approve with Contingencies For each issue:. Enter the Section that the issue is related to.. Enter a Description of the issue. 4. If the issue should be published, select Publish Issue. 5. If applicable, select which Reviewer is assigned to the issue. 6. If desired, enter Comments. 7. Click OK when you have entered all issues. Note: The issue(s) will appear under the issues tab in the Study Workspace. 7 STEP Send Approve with Contingencies Letter. Click Approve with Contingencies. Last updated: 0//07 6 of 4 v..6
7 Approve with Contingencies Approve with Contingencies Window 4. 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. All issues marked as publish issue should appear on the approval letter.. Edit the letter, if necessary. 4. Click OK. Note: This action sends the letter to the study team and changes the state of the submission to Contingencies Pending. STEP Refer to Reviewer eresearch Home Workspace. Once the study team submits the requested contingencies, the submission will display in the Core Staff owner s Inbox.. Click View Study to determine if the contingencies have been met.. If necessary, click Refer to Designated Reviewer. Last updated: 0//07 7 of 4 v..6
8 Approve with Contingencies STEP 4 Enter Completion Date for Contingencies. Select Edit Open Issues. Edit Open Issues Window For each issue:. If applicable, update the information about the issue(s).. If the issue is complete, select Completed. 4. Click OK. Last updated: 0//07 8 of 4 v..6
9 Approve with Contingencies STEP 5 Issue Approval Letter. Click Approve. Approve Window. 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. 4. Click OK. Note: This action sends the letter to the study team and changes the state of the submission to Approve. 4 Last updated: 0//07 9 of 4 v..6
10 Action Deferred Important Information: Disapprove The PI has the right to rebut or decline the right to rebut when a study is disapproved.. Click Disapprove. Disapprove Window. 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. 4. Click OK. Note: This action sends the letter to the study team and changes the state of the submission to Disapproved. 4 Last updated: 0//07 0 of 4 v..6
11 Action Deferred Action Deferred. Click Action Deferred Pending Study Team. Action Deferred Window. Click OK. The study returns to the Core Committee Staff Review state. See the Requesting Changes procedure for more information on requesting changes from the study team. Once changes have been submitted, you must reassign the study to a new meeting for review. Last updated: 0//07 of 4 v..6
12 Tabled Tabled Approve Window. Click Table. Approve Window. Click OK. The study is tabled for the current meeting. You will need to select a new meeting where the study can be reviewed. Last updated: 0//07 of 4 v..6
13 Finalizing Documents Important Finalizing Documents When the study is approved, Core Staff finalize the consent and recruitment forms for the study. Finalizing the consent and recruitment forms moves the documents into the Finalized Documents area and, if the documents were composed with the correct templates, watermarks the documents with the IRB Name, Study Number, Approval Date, and Expiration Date. The document is locked from editing when it has been finalized.. Click Finalize Documents. Finalize Documents Window 4. Select the documents to be finalized by checking the box next to each document.. Review the Approval Date and Expiration date and edit if necessary. 4. Check the Merge Fields Override box if you want documents without merge fields to be finalized. 5. Click OK. 5 Last updated: 0//07 of 4 v..6
14 Finalizing Documents Study Workspace 6. Finalized documents are moved to the Currently Approved Documents section on the Documents tab. Note: Click on the document to view the finalized version. 6 Last updated: 0//07 4 of 4 v..6
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