Reminder: Investigator Agreements and Financial Disclosure forms should be present in the Study Personnel files (referenced above) for all FDA regulated research studies. ☐ Not Laboratory Aspects of the Trial Yes No N/A Notes Reviewed Are current copies of laboratory accreditation(s) and certification(s) ☐ ☐ ☐ ☐ present (e.g. CLIA, CAP)? Are normal value(s)/range(s) for medical, laboratory, technical ☐ ☐ ☐ ☐ procedures present? ☐ ☐ ☐ ☐ Is an inventory of lab kits/supplies ☐ ☐ ☐ ☐ present and up to date? Have all lab kits/supplies been ☐ ☐ ☐ ☐ utilized before the expiration date? Are Research Sample/Specimen ☐ ☐ ☐ ☐ Logs present and up-to-date? TIP: A Research Sample/Specimen Tracking Log template is included in the . This log can be used after the sample is processed and ready for storage in a freezer or refrigerator. ☐ Not Equipment Yes No N/A Notes Reviewed Are temperature logs for applicable equipment complete and current ☐ ☐ ☐ ☐ (refrigerators, freezers, storage cabinets, etc.)? Are equipment maintenance and calibration records available and current (electronic scales, electronic ☐ ☐ ☐ ☐ blood pressure cuff, etc.) (if applicable)? Have changes in equipment been ☐ ☐ ☐ ☐ documented appropriately? ☐ Not Communication and Correspondence Yes No N/A Notes Reviewed Has documentation of correspondence (letters, e-mails, meeting notes, telephone calls) with ☐ ☐ ☐ ☐ the research sponsor and/or contract research organization (CRO) been maintained and filed? Has the monitoring log been signed ☐ ☐ ☐ ☐ and dated?
Reminder: Investigator Agreements and Financial Disclosure forms should be present in the Study Personnel files (referenced above) for all FDA regulated research studies. Laboratory Aspects of the Trial Yes No N/A ☐ Not Reviewed Notes Are current copies of laboratory accreditation(s) and certification(s) present (e.g. CLIA, CAP)? ☐ ☐ ☐ ☐ Are normal value(s)/range(s) for medical, laboratory, technical procedures present? ☐ ☐ ☐ ☐ ☐ ☐ ☐ ☐ Is an inventory of lab kits/supplies present and up to date? ☐ ☐ ☐ ☐ Have all lab kits/supplies been utilized before the expiration date? ☐ ☐ ☐ ☐ Are Research Sample/Specimen Logs present and up-to-date? ☐ ☐ ☐ ☐ TIP: A Research Sample/Specimen Tracking Log template is included in the . This log can be used after the sample is processed and ready for storage in a freezer or refrigerator. Equipment Yes No N/A ☐ Not Reviewed Notes Are temperature logs for applicable equipment complete and current (refrigerators, freezers, storage cabinets, etc.)? ☐ ☐ ☐ ☐ Are equipment maintenance and calibration records available and current (electronic scales, electronic blood pressure cuff, etc.) (if applicable)? ☐ ☐ ☐ ☐ Have changes in equipment been documented appropriately? ☐ ☐ ☐ ☐ Communication and Correspondence Yes No N/A ☐ Not Reviewed Notes Has documentation of correspondence (letters, e-mails, meeting notes, telephone calls) with the research sponsor and/or contract research organization (CRO) been maintained and filed? ☐ ☐ ☐ ☐ Has the monitoring log been signed and dated? ☐ ☐ ☐ ☐
Self-AuditToolRegulatoryFileReview-2016_11_11_clean.docx