Study Amendment Review Process
During the course of a clinical study, changes or amendments to the existing and approved study may be necessary.
The School of Medicine has developed a process to ensure all study amendments and changes are evaluated to ensure that all administrative, financial, contractual, and compliance requirements are evaluated and updated as necessary based on the study revisions proposed.
Changes to a study may include, but are not limited to:
- Protocol revisions
- Informed Consent revisions
- Contract amendment
- Budget amendment
Click here to review the full requirements for School of Medicine Process for Study Amendments and Revisions.