Protocol Adherence Checklist

Instructions: Use this checklist to ensure your human subjects research activities are performed in accordance with the USF IRB-approved protocol and application, and that any changes to your research activities are submitted to and approved by the USF IRB prior to implementation. Documentation typically reviewed to verify and meet each checklist item is indicated in italics whenever possible. Best practices for addressing specific checklist items are indicated by a star ().

Adherence to the USF IRB-Approved Protocol
ð IRB approval for the study was continuous
ð Participants were enrolled on the study (signed the informed consent document) during IRB-approved study periods
ð Number of participants enrolled on the study was confined to the IRB-approved protocol limitations
ð Recruiting/Screening criteria were met and documented for each individual approached for study enrollment as stated in the IRB-approved protocol
Note: Any advertisement used in human subjects research activities (“recruitment advertising”) requires prior review and approval by the USF IRB. Examples of recruitment advertising may include, but are not limited to: bulletin boards, flyers, newspapers, television, and radio advertisements. The IRB must review and approve all methods used to recruit subjects.
ð Inclusion/Exclusion criteria were met and documented for each participant as stated in the IRB-approved protocol
ð Study Procedures were met and documented as stated in the IRB-approved protocol
ð Follow-up Procedures were met and documented as stated in the IRB-approved protocol
ð All modifications to your human subjects research activities were approved by the IRB prior to implementation
Note: If research activities were performed differently from those defined in the IRB-approved protocol or application, this must reported as a protocol deviation to the USF IRB. Be sure to include in your report the reason for the deviation; whether or not this was an isolated event or an event which requires modifying the protocol going forward; and any affects on the safety and welfare of the participant as a result of this protocol deviation.
ð Study procedures were adequately documented to demonstrate all evaluated subjects existed and were alive and available for the duration of their stated participation in the study
ð Tests and measures were performed and documented by the presence of source documents as described in the IRB-approved protocol
Examples: laboratory results, pathology reports, x-rays, surveys, psychological assessments, questionnaires
ð Participants’ records were accurate in relation to source documentation
ð The reason(s) for participant withdrawal were documented in the research records
ð For Sponsored Studies, the reasons for participant withdrawal were reported to the study sponsor
ð Raw data files were organized, complete, and legible

USF Version: 20150528