Jump to content
Placeholder image for header
School of Medicine

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.

Study teams are required to submit a study amendment notification to SOMCT@vcu.edu for evaluation when a study change has been identified.  This is required for all IRB full-board or expedited approved clinical studies.