Protocol Enrollment Exception Request

A potential study participant meets all study entry criteria with the exception that inclusion criteria specify that participants must have an MRI within 14 days prior to enrollment — the potential participant’s most recent MRI is 18 days prior to enrollment. A one-time exception may be granted because the change does not significantly affect the welfare of the participant or the protocol design.

Submit a Protocol Enrollment Exception Request Form via iRIS

• Include approval from the study sponsor or, if there is no sponsor, from the Principal Investigator (PI) (see below).
• Ensure all questions are answered thoughtfully and completely.
• If enrollment in this study poses new risks not currently listed in the approved consent form, or increases the likelihood or severity of experiencing the known risks, you must include an addendum consent form with the submission​

Changes in entry criteria also require approval from the study sponsor or cooperative group. Approval from the study sponsor is required and must be uploaded within the Protocol Enrollment Exception Request Form. If there is no study sponsor, confirmation from the PI must be provided.

An IRB Chair or Vice Chair can approve the request if it constitutes a minor change to the study. The Chair or Vice Chair may decide that the change requires a higher level of review, and additional documentation may be requested.

Data collection should be reported using the standard study case report forms and become part of the scientific evaluation of the test article.

For step by step guidance on how to fill out the form, refer to the Protocol Enrollment Exception Request Form Quick Guide (MyAccess login required).