protocol violation/deviation

Site

Patient Number

Please enter in three digit format (e.g., 001, 002, ..., 025)

Is this an original or revised submission?

Original

Revised

Name of the Person Entering Data into this CRF

First Name

Last Name

THIS CRF SHOULD BE COMPLETED FOR EACH PROTOCOL DEVIATION

Date of Protocol Violation

YYYY

Brief Description of Protocol Violation/Deviation

Action Taken

Attestation

I approve the data entered into this CRF and attest to its accuracy.

Date of Completion

YYYY

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