How to sign a correspondence in Kuali Coeus
By Jamie Van Natta
Last modified 2/21/2014
Version 1.0
Overview:
There are several types of correspondence in ORCA that will now be generated and signed within the application. You
will be requested to sign these correspondences by your IRB administrator either via email or via a notification in the
system or both. The email and the notification will give you an indication of the action you are being requested to take.
The primary correspondences that require signatures are:
Approval - for convened protocols, amendments and renewals.
Expedited Approval - for expedited protocols, amendments and renewals.
Grant Exemption - for exempt protocols.
Specific Minor Revisions - for all protocols, amendment and renewal requiring additional information or clarification but
otherwise approved.
Substantive Revisions Required - for all protocols, amendment and renewals requiring substantial reworking and resubmission for review again before approval can be considered.
Termination - for all protocols that have completed all work, data analysis and presentation or publication.
Each of these correspondences is created by an “action” in the system performed on that specific protocol. Each of
these correspondences allows for comments to be added prior to creating the correspondence that will be included in
the correspondence itself. These comments will be entered or modified by the IRB administrators, but should be
reviewed by the signatory before performing the action.
Your IRB administrator will notify you when a signature is required, and what action is required. This guide assumes that
you will have this information.
The steps to signing a correspondence are very similar for all the different correspondences. This guide will first
describe the process, and then address each specific correspondence.
Step 1: Search for the protocol
Step 2: Review the comments to be included.
Step 3: Commit the action.
Step 1: Search for the protocol
1. Login to the system: https://myorca.utoledo.edu using your UTAD username and password. You will land on a
page that looks like this:
2. The IRB Protocol section is the top section and in the middle column.
3. Click the “Search Protocols” link, 3rd from the bottom. This will bring you to a look up page.
4. In the Protocol #: text box, enter the number from the notification or the email from your IRB administrator.
5. Click
. This will return the protocol on which you will be performing the action.
6. Click the edit link on the far left of the returned record. This will take you to the protocol itself.
All protocol information is available at this time if you wish to review the protocol again before signing.
Step 2: Review the comments to be included in the correspondence.
1. Go the
tab.
2. Expand the
tab by clicking the
button.
3. The available actions will be different depending on the type submission and the current status of the protocol.
Refer to the notification or email sent by the IRB administrator to determine which action you are being
requested to perform.
4. Expand the requested action by clicking the
button to the left of the action.
5. Depending on the requested action, there may or may not be comments associated with the action from the
review, pre-review or post-review. To see the comments that will be included in the correspondence, expand
the review comments by clicking the
button to the left of the
6. If there are comments, they will appear in a list now in the following format:
section.
7. If the comment is marked Final, and not Private, then the comments will be printed on the correspondence.
8. Review the comments for correctness and appropriateness. These comments will be part of the signed
correspondence with your signature on it.
Step 3: Commit the action.
1. The different actions will each have a slightly different format. Complete the fields required for the action as
listed below.
Grant Exemption
A. Change the Approval Date is to the date of the review. Refer to the notification or email from the IRB
administrator for the review date.
B. You are welcome to write a short comment for the protocol history if desired.
C. The action date should be today, the day you are signing the correspondence.
Expedited Approval
A. Change the Approval Date is to the date of the review. Refer to the notification or email from the IRB
administrator for the review date.
B. The expiration date will change automatically to one year from the approval date.
C. You are welcome to write a short comment for the protocol history if desired.
D. Make sure the “Include in an agenda?” checkbox is checked. If there is no schedule date listed, choose the
next date chronologically.
E. The action date should be today, the day you are signing the correspondence.
Approval
A. Change the Approval Date is to the date of the review. Refer to the notification or email from the IRB
administrator for the review date.
B. The expiration date will change automatically to one year from the approval date.
C. You are welcome to write a short comment for the protocol history if desired.
D. The action date should be today, the day you are signing the correspondence.
Specific Minor Revisions
A. You are welcome to write a short comment for the protocol history if desired.
B. The action date should be today, the day you are signing the correspondence.
C. It is especially important to confirm the review comments for this correspondence. If you find have any
questions or issues with the comments, DO NOT click the submit button. Contact your IRB Administrator
to go over the comments.
D. If you are content with the comments listed, continue to the next step.
Substantive Revisions Required
A. You are welcome to write a short comment for the protocol history if desired.
B. The action date should be today, the day you are signing the correspondence.
C. It is especially important to confirm the review comments for this correspondence. If you find have any
questions or issues with the comments, DO NOT click the submit button. Contact your IRB Administrator
to go over the comments.
D. If you are content with the comments, continue to the next step.
Termination
A. Confirm that the Action Date is appropriate.
B. You are welcome to add a comment for the protocol history if desired.
2. Under the review comments section, click the
button. This constitutes your signature. The page will
process for a few seconds and you will be taken to the correspondence e window.
3. Click the
button to the left on the
show the correspondence generated by the action.
4. You can view the correspondence that was generated by clicking the
folder. This will bring
button on the right of the line.
5. Click the
under the word Final to indicate the completion of the correspondence and to release the
document to the P.I.
Congratulations! You have now completed the signing of the correspondence.