Sponsors and PI’s are responsible for submitting changes to research materials.Study changes may not be implemented prior to receiving IRB approval. Amendments may be submitted to full board following the same timelines listed for Initial Submissions. However, changes to research may also qualify for expedited review. Expedited review items will be reviewed within 72 hours of submission. Your IRB contact will inform you of the type of review your submission will follow. All changes to research must be submitted through eProtocol. Examples of changes that should be submitted for approval include:

• Amendments and changes to the protocol including any administrative changes
• Recruitment materials, questionnaires, instructions, etc. developed after the initial submission or changed during the course of the study
• Changes occurring at the Site
  • Change in PI
  • Any change in Primary or Additional site locations
  • Increases in enrollment
  • Changes to planned study population
  • Protocol deviations (even deviations pre-approved by the sponsor)
  • Notification of study closure/completion