Form 2: Change Request & Amendments. Revised: May 2014

Transcription

1 Form 2: Change Request & Amendments 2014 Revised:

2 Submitting a Form 2: Change Request/Amendment via imedris How to Submit a Form 2: Change Request/Amendment via imedris 1. Open your web browser. 2. Go to the UTK IRB electronic system, imedris at and the imedris login screen will appear: 3. Login using your UT Net ID and password. 4. The system will automatically take you to your imedris homepage. 2

3 5. On the left side of your screen, under the Study Assistant tab, click My Projects. 6. You will see your list of studies/projects. Click to Open the study you wish to change/revise. 7. On the Submissions screen, click Form 2: Change Request & Amendment. 3

4 8. Click Add a New Form to open a new Form 2: Change Request/Amendment. 9. The first section of the Form 2 (Section 1.1) is read-only and provides general information about your study. 4

5 10. Scroll down the page. In Section 1.2 of the Form 2, indicate the number of subjects that are currently enrolled in your project (if any) and indicate the items you will be revising/changing. You must provide a response to each question. Once you have answered each question, click Save and Continue. 5

6 11. If you forget to respond to a question, you will receive an error message. Click Ok, and make the appropriate correction. Click Save and Continue when you are done. 12. On the next screen, click Add a new row to describe the changes/revisions that will be made to the electronic study application., if applicable. 6

7 13. Describe each revision and click the gray bar to revise and attach the new version of your study application. 14. You will see each version of your study application that has been reviewed and approved by the UTK IRB. Click Add Revision to incorporate your changes/ revisions to study application. 7

8 15. You will be asked to confirm that you want to create a revision to your study application. Select Ok. 16. A new version of the application will open for you to modify. Be sure to click Save and Continue after each change is made. 8

9 17. When you have completed the revisions to the study application, you will be prompted to select the revised study application you would like to attach to your Form 2. Be sure to click Save Attachment. 18. Once revised study application is attached, Click Save and Continue. 9

10 19. If you need to make changes to your consent form, you will need to describe each of the changes/revisions, just as you did with the study application. Click Add a new row to describe each change. 20. To revise and attach your updated consent form, click Select or Revise Existing. 10

11 21. Next, you will create a revised version of your currently approved consent form so that you can make the appropriate changes. Click the icon under Create Revision. 22. Next, you will want to Check-out the consent form to make the appropriate changes. 11

12 23. You will receive a prompt asking whether you want to open or save the consent document. Select Open. 24. Your consent form will open in Word so that you can make the appropriate changes. Once you have completed your changes to the consent form and updated the preparation date in the footer, save a copy to your computer. 25. Next, in imedris, click Complete Checkout. 12

13 26. Next, you will receive a prompt asking if you would like to check the document back into imedris. Click Check-in Document. 27. Locate the revised consent form on your computer by clicking Browse. 13

14 28. Locate the document on your computer, select it, and click Open. 29. Next, select Save selected file and the document will be uploaded into imedris. 14

15 30. Make sure that the consent title, version number, and version date are correct and click Save Consent. 31. The revised version of the consent form is now attached to the Form 2. Click the red x in the right corner to close out of the screen and return to the Form 2: Change Request/Amendment. 15

16 32. Once you have outlined each of the change(s) to the consent form and attached the revised consent form, click Save and Continue to move to the next screen. 33. Address whether the changes affect the risk/benefit ratio and click Save and Continue. 16

17 34. Next, indicate whether you have any additional study documents to attach. If you do, click the appropriate gray button and follow the same steps for attaching study documents as outlined above. If you have no additional study documents to attach, indicate this and click Save and Continue. 35. The last question in the Form 2 provides a text box for you to provide any additional information you need to share with the IRB. Next, click Sign and Submit to route the Form for appropriate signature(s). 36. To verify who will receive the Form 2 for signatures, click Yes and Save and Continue. 17

18 37. Select the appropriate key study personnel for signatures. Note: If a new investigator(s) is being added to the study, the application will need to be routed to each new investigator for signature(s). 38. If there are not additional personnel required for routing and signature, click Save and Continue. 39. You will be asked whether you have completed your selection of required signatures. The system automatically defaults to Yes. If your selection of key study personnel required to signoff on the submission is complete, click Save and Continue. If not, change your response to No and click Save and Continue. 18

19 40. You may verify the electronic signatures in the Workflow Tracking of imedris. 41. For more instructions regarding routing and signoff, download the imedris Guide Routing, Workflow Tracking & Signoff from the IRB website at In addition, do not hesitate to contact the IRB office at for assistance. 19