1. How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides.

2. Log in to DISCOVR-E. 1. Go to the E-Submissions tab 2. Look under Submissions Requiring a CAL Response 3. CAL letters that have been sent will be listed 4. When you are ready, just Click to Respond

3. When you click on the Click To Respond link, a box will come up, as shown, letting you know that a response submission will be started. Simply click OK

4. As prompted, simply click the Next button.

5. The previous click brings you to the Submission Wizard, as shown below. Here you are prompted to click Next to continue.

6. After the click, you come to the beginning of the form you originally filled out. The form is now completely editable. 1. If the committee asked for changes to anything in this form, make them now, as you go through the form page by page. 2. If the requested changes apply elsewhere (the consent form, protocol etc.), click the Next button to go on to the Attachments page.

7. This is where you attach your revised documents. Simply click the dropdown arrow and select the Type of document you wish to upload.

8. The Browse button will appear and you can simply browse to where you have the revised document saved on your computer.

9. Double click on your file and it will upload. Consent Form was the choice from the dropdown list on the previous page and it is now shown in the Type window.

10. Your form has been uploaded but there is no place on this page to enter your comments. This is by design. Please do the following: 1. Create a Word document 2. Include an itemized list of the requested changes 3. Include an itemized list with your response to each change 4. Upload it just like you did the consent form.

11. Choose Other and Browse to the CAL Response document you prepared and have saved on your computer.

12. Same thing here: Double click on the document and it’s uploaded.

13. With all your revised documents and the CAL Response document attached, click Next to continue.

14. If you are the coordinator, you will see a list of the signatories to whom the submission will be sent for e-signature. Since this is a CAL Response, the PI must sign. Click Next and you are done. The PI will be notified by email and prompted to sign the response. As soon as that’s done the response is routed to the IRB for processing. If you are the PI, you can sign on the next page.

15. If you are the PI, scroll down: 1. Enter your password 2. Click the Sign button 3. Log out – you are done.

16. After you sign, the verification box will show you that the response has been submitted to the IRB.