REQUEST FOR MODIFICATION version February 2025

REQUEST FOR MODIFICATION

version February 2025

IRBNet ID number and full study title*

Principal Investigator*

include credentials

contact information*

Please include a valid email address.

KEY PERSONNEL*

Include name, credentials, department, and study role.

Study Status*

Select or enter value

number of active participants

total enrollment to date

Request type*

INSTRUCTIONS PER MODIFICATION TYPE(S) SELECTED

1) Add to submission for IRB review and consideration. If this is a revision to an existing document include both

tracked and clean versions of the document.

2) Add both tracked and clean versions of the document for IRB review and consideration.

3) Indicate new target number and rationale.

4) Add statement addressing whether or not the changes affect the protocol or consent documents. If yes, ensure

that both the protocol and consent boxes above are checked and that the appropriate documents accompany this submission.

5) NOTE: new additions to the study team must complete the research education requirements prior to conducting

any research related activities.

6) Add both tracked* and clean versions of the document for IRB review and consideration. *A summary of

changes document may be used in place of a tracked version if not available. Include a statement that the PI and study team are aware of the changes and indicate whether or not the changes affect the overall risk/benefit ratio of the study.

7) Such items can be and are not limited to: DSMB reports, general information, etc... Include statement that the PI and study team are aware of the information.

Select or enter value

Explanations/expansions on selections above*

Date

_________________________

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