An amendment is requested by the researcher to make a change to a previously approved protocol. This change may be procedural or informational. Probably the most common amendment is a change to the personnel working on the project. Other reasons for an amendment include:
- An increase in drug dosage or duration of the subject’s exposure to the drug;
- A significant increase in the number of study subjects;
- The addition of a new test or procedure that is intended to improve safety monitoring or the elimination of a test intended to monitor safety; or
- The elimination of an apparent, immediate hazard to subjects.
- A general rule to follow is if the goals of the study are the same, an amendment is needed merely to modify any of the previously mentioned items. However, if the goals of the amendment diverge from the goals of the approved protocol, you will need to submit a new protocol application.
Figure 212 Protocol Document, Protocol Actions Page – Request an Action Section, Available Actions, Create Amendment Section
Create an Amendment
Click the create button and a new protocol document will be opened. All questions regarding the amendment will be located on the Questionnaire page.
Multiple Amendments
To ensure continuity of all protocol information, only one amendment can be submitted at a time in WVU+kc. If additional changes need to be made on a protocol that already has a submitted amendment waiting on approval, there are two options to consider:
- Wait for the submitted amendment to be approved and then submit another amendment for the additional new information.
- Request the ORIC return your submitted amendment for Specific Minor Revisions, make the additional changes, upload a revised amendment form, and resubmit the fully-amended protocol.
Submit an Amendment
After making the necessary changes within the protocol document, navigate to the Submit for Review subsection of the Request an Action section.
Figure 214 Protocol Document, Protocol Actions Page – Request an Action Section, Submit Amendment for Review
Select “Amendment” from the drop-down menu in the Submission Type field. The protocol type will automatically be selected from the drop-down menu in the Submission Review Type field. Click the submit button to submit the amendment.
- While working on an amendment, your protocol number will have a suffix beginning with A, such as 1401125338A0001. This suffix indicates that the protocol is an amendment. The status "Amendment in Progress" means that the amendment is currently being edited for submission and HAS NOT been submitted. The status "Routing Protocol" means the amendment has been submitted. Once an amendment has been approved by the IRB, the suffix on the protocol number will no longer appear.
Delete Amendment
To delete an amendment, see Delete Protocol, Amendment, or Renewal.