Document Name


Application Submission

Required for studies involving participants – the checklist should be used when creating the informed consent. Note OHRP last reviewed the content in 2014 but made no revisions.

Required for studies involving children ages 8-18 years of age.

Required for studies using HIPAA information.

Required for all study modifications.

Required when a new conflict of interest is identified

Required when an adverse, unanticipated event or violation occurs