Managing Your Protis Protocols

As of February 19, 2020, The USU IRB is utilizing Kuali Protocols as its primary submission portal. Protocols that are Active in Protis will remain that way for the foreseeable future; this page will assist you in maintaining your Active protocols.

Amendments

Amendments are modifications to the currently approved protocol, and they must be submitted in advance of the implementation of the requested change. Amendments must be prospective in nature – that is, you may not submit an amendment for procedures or processes you have already changed. To amend an Active protocol, review the entirety of your protocol to identify areas where you may wish to make a change. Each and every field affected by the change must be amended.

Do not submit your amendments to the “Submit” tab, unless you are amending an upload previously provided there. Amendments must be submitted to the field that is affected by the change. The “Submit Amendment” tab is where you go to actually submit the amendment for the IRB’s review, not where the substance of the amendment should be entered.

This is an example of amending the necessary fields for a change in the age range utilized in this project:

Step 1: Identify the field you wish to amend. In this example, we are amending the age range, so the question about the age range (represented by the purple arrow) is the item we want to target for our amendment.

Step 2: Click “Amend this Field” (represented by the orange arrow) for the field you have previously identified as requiring a change.

Note: Protis’ programming is quite old and as a result, many browsers struggle with the amendment function. We have found that it performs best in Google Chrome; even then, you may need to wait about a minute between clicking “Amend this Field” and the amendment dialog box appearing.


Step 3:
Explain the changes that are needed to the field you have selected to amend. Upload a supporting document if you need to.


Note: Protis amendments do not support rich text formatting. The use of bold, underline, and even returns will not save into the final amendment text, so simply type the text you require into the allotted space.
 


Step 4:
Save the amendment. Once saved, you have the option to edit or delete if necessary.


Step 5: Verify that the text you have entered in support of your amendment has saved to the appropriate field. Review the protocol for any other fields you may need to edit. In this example, we will also provide social media recruitment materials we had not previously used.

Step 6: Amend the field as many times as necessary to complete the changes you are requesting. In this example, we want to provide two documents in support of our amendment; thus, you can see that two separate amendments have been uploaded.


Note: You can amend one field as many times as is necessary to provide complete information about your proposed amendment. 



Step 6a: When amending your informed consent documentation, you must work from the “Approved” Word version provided in the protocol. It is locked for tracked changes so that reviewers can identify which changes you require; failure to work from that version will result in immediate amendment denial.

Step 7: You can review all of the areas of the protocol where you have entered amendments by checking to verify the “#+” items on the Section Tabs correspond with the number of amendments you have saved to those sections.


Step 8: After all of the relevant fields have been entered into the protocol, go to the Submit Amendment tab to Submit your Amendment.


Step 9:
Verify that the yellow Status Bar at the top of the page says “Amendment Status: New” instead of “Amendment Status: Pre-submitted.” Pre-submitted amendments are amendments that you have entered into the protocol, but which have not been submitted to the IRB for review.