When an amendment to a study protocol is made, please contact the Clinical Trials Office (CTO). Please include:
- Amended protocol
- Model consent
- IRB (Institutional Review Board) consent form
- Any additional documents related to the study
We request that the submission of the amendment be made well in advance of submission to the IRB, whenever 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 every effort to get the revised MCA to the research team before the IRB approves the amendment.
The study contact will receive a confirmation number via email once the form is submitted.