COMIRB Database Electronic Submission Electronic Amendment (Change Form)

1. COMIRB DatabaseElectronic SubmissionElectronic Amendment (Change Form) An electronic Amendment/Change From process should ONLY be done if a previous electronic submission has been completed. If you are current in the paper process continue to submit changes In paper. Revised: 3-1-2011

2. To gain access into the COMIRB Database you will need the following: • A current and active POI Number. • Unsure what a POI Number is and how to obtain yours, view training Video – http://connect.ucdenver.edu/accesstraining • A current and active UC Denver email account with Login access. • Unsure how to get your UC Denver email account, view training video – http://connect.ucdenver.edu/laccesstraining • - http://connect.ucdenver.edu/loginandprofiletraining • At this point you can use any internet browser to access the COMIRB Database: https://era.cu.edu • You can view the training video on how to search for your protocols - http://connect.ucdenver.edu/lsearchprotocls

3. 1. Creating a Amendment/Change Form • Remember that an electronic amendment/change form should only be done after an electronic application has been submitted • and processed. • a. After logging back into your electronic submission locate the “Amendment” folder • b. Click on the title “Amendment” • c. Then Select “Add New”

4. 2. Processing the new Amendment/Change Form • a. Once the page refreshes you will notice a few things: • i) The change form has been create for you and is ready for your editing • ii) A list of previous documents that are on file. These can be includes and edited along with the change form. • - to add any of these previous documents, select the “Include box” next to the item • - Then select “Save” at the top of the page • iii) You also have the link “ Add Institutional Forms/Supporting Documents” in case you have to add new documents along • with this change request

5. 3. Creating the Change Form a. Once the page refreshes you will notice a few things: i) The items you selected will be includes as a component. These can be edited or re-uploaded ii) You still need to complete the mandatory “Change Form”. So select the edit icon to open the form.

6. 4. Completing the Change Form a) Once your Change Form opens, complete the form with all the required information. b) When you have completed the form you Can then check the completed box and close. c) If you have any missing areas or information the form will ask for those to be completed.

7. 5. Finalizing the Change Form Once you have completed or changed all the documents for your Amendment/Change Form. You can select “Submit” to complete the request as you did in the electronic application.