Actions for Active Protocols

After your IRB protocol has been approved, there may be various actions that you need to take during he course of the lifetime of the protocol. This guide provides basic instructions for actions that can be taken over the lifetime of an active (approved) IRB protocol.

View approval letter

From the main WVU+kc dashboard page, navigate to the IRB section of your research activity lists (on the LEFT side of the main display in the center of the page) and click on the Active Protocols tab at the top to display all approved and active protocols. Open the appropriate protocol for editing by clicking the pencil icon located in the Action column.

The protocol document will open to the Protocol Summary page. All letters of approval for the original protocol or for any amendments or renewals can be found in the Correspondence section of that page. To view a letter, click on the View button in the Actions column. Choose to open or save the file to your desired location. It is now available to print or save, as necessary.

Copy protocol

To create another protocol with the same Principal Investigator, personnel, title, department, questionnaire, and protocol type use the Copy to New Document feature on the Protocol Actions page.

To copy a protocol:

1. Open the protocol document for editing

2. Click on the Protocol Actions page/tab.

3. Click the Show button in the Copy to New Document section.

4. Click the Copy Protocol button. A new protocol document with a unique document number will be created.

Amend protocol

If you need to make changes to an approved protocol, you can begin an amendment from the Protocol Actions page of the existing protocol document.

Create the Amendment:

1. From the WVU+kc main dashboard page, click the IRB section in your research activity lists.

2. Click on the Amend or Renew tab to display all of your protocols that are available to amend or renew.

3. Open the protocol by clicking on the pencil icon located in the Action column.

4. Navigate to the Protocol Actions page, and click Show in the Create Amendment sub-section under Request an Action.

5. Click the Create button to initiate a new amendment for this protocol.

You will receive a message that you have successfully created your amendment. This message does not mean that you have successfully submitted an amendment for review. It means the protocol is now editable to make the appropriate changes related to your amendment.

While working on the amendment, your protocol number will have a suffix beginning with A, such as 1401183556A007. This suffix indicates that the protocol is an amendment and the number indicates the amendment number on the protocol. In this example, this is the 7th amendment for this particular protocol. The status “Amendment in Progress” means that the amendment is currently being edited for submission and HAS NOT been submitted for review.

Amend/edit the protocol:

• Personnel page: Make any changes to study personnel by deleting individuals who are no longer on the study, or adding new personnel.

• Notes & Attachments page: Delete any attachments that are no longer relevant to the protocol and/or replace old versions of documents being updated by the amendment.

• Questionnaire page: Complete the Amendment section. There may also be updates that you need to complete on the Questionnaire page before you can submit your amendment. If you see an Update Required message at the top of the Questionnaire page, review the Questionnaire Updates for IRB Protocol Documents article for additional guidance.

If you find that you need to delete the amendment you are currently editing, you can do so on the Protocol Actions page. 

1. Navigate to the Protocol Actions page.

2. Click Show in the Request an Action section.

3. Click Show to view the Delete Protocol, Amendment, or Renewal sub-section.

4. Enter the Delete Reason, such as 'created in error'.

5. Click the Submit button. WVU+kc will confirm that you want to delete the amendment. Click yes to confirm deletion.

Note: This action does not delete the original protocol, only the amendment. You will not be able to delete an amendment once it has been submitted for review.

Submit the amendment:

Once all of the changes have been made to the protocol, you can submit the amendment for review.

1. Navigate to the Protocol Actions page

2. Click show to open the Request an Action section

3. Click show to open the Submit for Review sub-section.

4. In the Submission Type field, select Amendment.

5. Click the Submit button to submit the amendment for review. Once you have submitted your amendment, the protocol’s status will change to Routing Protocol.

Continuing review

If your protocol requires continuing review, you can initiate this process by creating and submitting a Renewal for the protocol. After logging into WVU+kc, navigate to the IRB section of your research activity lists. Click on the Amend or Renew tab to display all of your protocols that are available for those actions. Open the protocol that needs renewed by clicking on the pencil icon in the Action column.

Create renewal:

1. Navigate to the Protocol Actions page of the protocol document.

2. Click Show to open the open the Available Actions area.

3. Click Show to open the Create Renewal with Amendment sub-section.

4. Click the Create button to begin editing the renewal document. You will receive a message that you have successfully created a continuing review. 

Note: This message does not mean that you have successfully submitted a renewal for review. Only one amendment or renewal can be submitted at a time on the same protocol. You also will not be able to create an amendment or renewal if you have an open Request such as a Notify IRB or Request to Close Enrollment.

Creating a Renewal makes the protocol editable so that the appropriate changes related to your renewal can be made. While working on the continuing review protocol document, your protocol number will have a suffix beginning with R, such as 1409430653R002. This suffix indicates that the protocol is an amendment and the number indicates the amendment number on the protocol. In this example, this is the 2nd continuing review for this particular protocol. The status Renewal in Progress means that the amendment is currently being edited for submission and has not been submitted for review.

Edit the renewal protocol:

Before submitting a renewal for continuing review, you may need to alter some of the content of the original protocol. 

• On the Personnel page, make any changes to study personnel by deleting personnel who are no longer on the study or adding new personnel.

• On the Notes & Attachments page, be sure to delete any attachments that are no longer relevant to the protocol and/or replace old versions of documents that are being updated by the amendment.

• On the Questionnaire page, complete the Continuing Review/Renewal section.

  • There may also be updates that you need to complete on the Questionnaire page before you can submit your renewal. If you see an Update Required message at the top of the Questionnaire page, review the Questionnaire Updates for IRB Protocol Documents article for additional guidance.

If at any time you find that you need to delete the renewal you are currently editing, utilize the Delete Protocol, Amendment, or Renewal action located in the Request an Action section on the Protocol Actions page of the renewal.

1. Navigate to the Protocol Actions page of the renewal protocol document.

2. Click Show to open the open the Delete Protocol, Amendment, or Renewal sub-section.

3. Enter the Delete Reason, such as 'created in error'.

4. Click the Submit button.

   • WVU+kc will confirm that you want to delete the renewal. Click the Yes button to confirm deletion.

Note: This action does not delete the original protocol, only the renewal. You cannot delete a renewal that has been submitted for review.

Submit renewal:

Once all of the changes have been made to the protocol and the Continuing Review/Renewal section has been completed on the Questionnaire page,

1. Navigate to the Protocol Actions page.

2. Open the Submit for Review sub-section located in the Request an Action section.

3. Select Continuing Review/Continuation with Amendment from the Submission Type field.

4. Click the Submit button to submit the amendment for review.

   • Once you have submitted your amendment, the protocol’s status will change to Routing Protocol.

Report an issue to the IRB

Report an issue with your protocol such as a deviation, violation, exception, UPIRTSO, or adverse event using the Notify IRB action:

1. Open the appropriate protocol and navigate to the Protocol Actions page.

2. Click Show to open the Notify IRB section.

3. Select the type of issue from the Submission Type Qualifier drop-down menu.

4. Upload a completed Deviation/Violation/Exception, UPIRTSO, or Adverse Event report in Add row of the Attachments area.

5. Enter a Description of the form.

6. Click the Add button in the Actions column to add the attachment to the protocol. Attach any other relevant documents as needed.

7. Click the Submit button to submit the information.

Upon submission, WVU+kc will populate a notification to inform you that the Notify IRB action has been submitted. Additionally, the action being processed will display in the Protocol History page of your protocol with the date it was submitted. You will also be able to view the form(s) attached and associated comments. Once the IRB has reviewed the information, it will acknowledge the action, which will also display in the History section. If any additional activity is needed to process the event reported, instructions will be conveyed in the comments section of the IRB Acknowledgement action. This information will also be conveyed in the system-generated email for the IRB Acknowledgement action.

Request to close enrollment

Request a status change to "Active – Closed to Enrollment":

1. Navigate to the Protocol Actions page in your protocol.

2. Click Show by the Request to Close Enrollment sub-section under Available Actions.

3. Enter a Reason in the text field.

4. Optionally, you can add an attachment to this request. Click Browse to upload a file, enter a Description of the file, and click Add in the Actions column.

5. Click the Submit button to send the request.

The IRB will receive the request and make a determination. It is possible the IRB will return the request. If so, a notification will be sent to the Principal Investigator with comments on why the request was returned. If another request is to be made, repeat the Request to Close action.

If the IRB approves the request the status of the protocol will change from Approved – Open to Enrollment to Approved – Closed to Enrollment.

Request to close protocol

1. Navigate to the Protocol Actions tab in the protocol document.

2. Click Show by the Request to Close sub-section under the Available Actions section.

3. Enter a Reason for closing the protocol.

4. Add a Closure Form to the Attachments area.

   • Click Browse to upload a file, enter a Description of the file, and click Add in the Actions column.

5. Click Submit to send the request.

It is possible the IRB will return the request. If so, a notification will be sent to the Principal Investigator with comments on why the request was returned. If another request is to be made, repeat the Request to Close action.

If the IRB approves the request the status of the protocol will change from Active – Open to Enrollment to Closed by Investigator.