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

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

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

How can I respond to an IRB CAL Letter?

It’s easy…just follow the steps on the next few slides.

Page 2: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

Log in to DISCOVR-E.

1. Go to the E-Submissions tab2. Look under Submissions Requiring a CAL Response 3. CAL letters that have been sent will be listed4. When you are ready, just Click to Respond

Page 3: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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

Page 4: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

As prompted, simply click the Next button.

Page 5: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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

Page 6: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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.

Page 7: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

This is where you attach your revised documents. Simply click the dropdown arrow and select the Type of

document you wish to upload.

Page 8: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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

Page 9: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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.

Page 10: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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 changes3. Include an itemized list with your response to each change4. Upload it just like you did the consent form.

Page 11: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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

Page 12: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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

Page 13: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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

Page 14: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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.

Page 15: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

If you are the PI, scroll down:

1. Enter your password2. Click the Sign button 3. Log out

– you are done.

Page 16: How can I respond to an IRB CAL Letter? It’s easy…just follow the steps on the next few slides

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