Protocol Amendments

All protocol amendments should be submitted to the Clinical Trials Office (CTO) for review by using the Amendment Submission Form. This form allows you to upload amended protocol, model consent, and other study material.

Amendment Submission Form

This form must be submitted to the CTO when there has been an amendment to the study protocol. Please include the amended protocol and model consent. If you have the consent form that you will submit to the CPHS, include that, too. If you have any additional documents related to the study, please include those as well.

We request the submission of the amendment well in advance of the submission to the CPHS when possible. Ideally, a three- to four-week lead is preferable to give us adequate time for CTO review, department review, and PI approval.

The CTO will make all best efforts to get the revised MCA to the research team before the amendment is approved by the CPHS.

The study contact will receive a confirmation number via e-mail upon submission of this form.

While each File Upload field can have attachments as large as 10MB, please remember that the maximum size for all attachments per entry cannot exceed 20MB. That doesn’t mean you can't have more than 2 File Upload fields on a form. It just means that your users can only upload 20MB worth of files at a time.

Amendment submission form