Subject Screening Log Subject Enrollment Log Randomization Log (If applicable) Organize Research Subject Records and Completed Comments Ensure Availability of the Following: Yes No Original Signed and Dated Informed Consent Documents for each research participant along with addendums as applicable Completed Case Report Forms Source documentation to support the subject: ☐ ☐ Met all entrance criteria ☐ ☐ Received test article per protocol Had f/u visits performed per protocol windows Had laboratory tests per protocol and lab reports were signed by the PI Had other diagnostic tests as applicable per protocol Was evaluated for and treated as applicable for AEs Documentation for protocol exceptions or deviations Ensure resolution of all queries
Subject Screening Log Subject Enrollment Log Randomization Log (If applicable) Organize Research Subject Records and Ensure Availability of the Following: Completed Yes No Comments Original Signed and Dated Informed Consent Documents for each research participant along with addendums as applicable Completed Case Report Forms Source documentation to support the subject: Met all entrance criteria Received test article per protocol Had f/u visits performed per protocol windows Had laboratory tests per protocol and lab reports were signed by the PI Had other diagnostic tests as applicable per protocol Was evaluated for and treated as applicable for AEs ☐ ☐ ☐ ☐ Documentation for protocol exceptions or deviations Ensure resolution of all queries
UOP_FDA_InspectionChecklist.docx