Coeus Extension IRB Administrative Process Grant Exemption/Expedited Approval (Initial Protocol or Amendment)

Transcription

1 Coeus Extension IRB Administrative Process Grant Exemption/Expedited Approval (Initial Protocol or Amendment) Complete the following steps only when ALL Reviewers have indicated Grant Exemption AND there are no Revisions Requested: IRB Protocol Submission Module Complete the following steps in the IRB Protocol Submission Module Step 1: Open IRB Protocol Submission 1. Identify Protocol Submission Number from Notification Submission number will be both in the Subject line and in the body 2. Launch Coeus Premium and open the IRB Protocol Submission module by going to Maintain > IRB Protocol Submission or clicking the IRB Protocol Submission icon. 3. IRB Protocol Search: The standard search window will open. Search by the Protocol number identified in the notification and click Find NOTE: If the search window is accidently closed, re open by clicking the IRB Protocol Search icon in the top navigation. NOTE: Search criteria may be abbreviated by using the asterisks key (*) as a wildcard. Example: Protocol can be searched by *385* 4. Select appropriate submission listing by single clicking to highlight Step 2: Open Review Comments You may access the Review Comments associated to the submission by two different methods. 1. Open Review Comments Directly a. Make sure the proper submission is highlighted on the IRB Protocol Submission List b. Go to: Edit > Review Comments 2. Open Review Comments through Submission Details NOTE: If you open Review Comments through Submission Details there is a risk of comments being saved out of order. It is recommended to complete all edits by opening the Review Comments directly. a. Make sure the proper submission is highlighted on the IRB Protocol Submission List b. Open Submission Details screen by going to: Edit > Submission Details or clicking the Submission Details icon. c. Click the Review Comments button. 1 P age

2 Step 3: Scrub Review Comments 1. Mark ALL previously entered comments Final and Private a. Select the Comment to update and click Modify b. Check the boxes for Final and Private if they are not already c. Click Save & Close d. Repeat for all remaining comments 2. Consolidate Final Comments a. Identify Member Comments to PI b. Consolidate and rewrite comments outside of system into one official list of comments to be sent to PI 3. Enter Final Comments to Investigator a. Click the New button b. Enter first official comment NOTE: You CAN copy and paste into Coeus by using Ctrl C & Ctrl V. c. Check the Final box d. Ensure the Private box is NOT checked 2 P age

3 e. Click Save & New to enter next comment f. Repeat for all remaining official comments g. When final comment is entered, click Save & Close h. Click Close to exit Review Comments window 4. **For approvals of all Amendments to previously granted Exemptions: Be sure to enter a review comment stating which Amendment is being granted the Exemption (i.e. Amendment A002 ) Step 4: Grant Exemption Initial Protocol 1. Select the submission to be approved on IRB Protocol Submission List screen 2. Go to Actions > Grant Exemption 3. Enter appropriate Approval Date 4. Enter appropriate Action Date 5. Confirm Review Comments a. Click Review Comments b. Review all comments and confirm internal comments are marked Private and comments to be sent to PI are not c. Click Close Action screen 6. Click Ok to finalize Approval Action 3 P age

4 7. With the Correspondences List window open, click View to open to open CES Exemption Granted Letter 8. New browser window will open with the generated CES Exemption Granted Letter 9. Review for accuracy 10. Save memo to desktop d. Save as.pdf e. Name file: protocol number_yyyy.mm.dd f. Close browser window 11. Check the Final box next to the CES Exemption Granted memo and Save 12. Click Close Process Expedited Approval for Exempt Amendment (IRB Protocol Submission Module) Step 5: Expedited Approval Exempt Amendment 1. Select the submission to be approved on IRB Protocol Submission List screen 2. Open Submission Details screen by going to: Edit > Submission Details or clicking the Submission Details icon. 3. Change Review Type to be Expedited 4. Click Checklist to open list 5. Check box next to: 16 Amendment to Exempt Research resulting in continued Exempt status. 6. Click OK on Checklist for Expedited window to close 7. Click OK to close and save Submission Details screen 8. Go to Actions > Expedited Approval 4 P age

5 10. Confirm Review Comments g. Click Review Comments h. Enter comment to identify Amendment number i. Amendment 00X i. Review all comments and confirm internal comments are marked Private and comments to be sent to PI are not j. Click Close to return to Action screen 11. Click Ok to finalize Approval Action 12. With the Correspondences List window open, click View to open CES Exemption Granted Letter 13. New browser window will open with the generated CES Exemption Granted Letter 14. Review for accuracy 15. Save memo to desktop k. Save as.pdf 5 P age

6 l. Name file: protocol number_yyyy.mm.dd m. Close browser window 16. Check the Final box next to the CES Exemption Granted memo and Save 13. Click Close Step 6: Send Notification 1. When the Correspondence List closes, the Send Mail window will automatically open 2. Add additional Recipients a. PI will default populate b. Click Add Person c. Complete the standard Person Search d. Repeat for all additional recipients NOTE: To Remove a recipient, highlight and then click the Delete button 3. Click Send Step 7: Assign to Schedule 1. Window will automatically display asking to include submission in an Agenda, click Yes 6 P age

7 2. On Assign to Schedule window, click Select Committee 3. Click CES to highlight and click OK 4. Return to Assign to Schedule window, click Select Schedule 5. Click the next available date and click OK 7 P age

8 6. Return to Assign to Schedule window, confirm all fields are filled in, and click OK 7. Confirmation window will display, click OK again Step 8: Extension Educator Exemption Granted Letter Upload 8. Double click the submission to open record in Display 9. Click on the Attachments tab to open screen 10. Click the Other Attachments tab 11. In the Other Attachments section, click Add 12. Document Type: Select IRB Approval Letter 13. Description: Enter protocol number_yyyy.mm.dd 14. Click the Browse button to upload the saved correspondence 15. Click Ok and Save record. 16. Exit submission. 8 P age