Is an IRB member roster present and up to date? ☐ ☐ ☐ ☐ Is an FWA present and up to date? ☐ ☐ ☐ ☐ Has a final protocol closure report been submitted to regulatory authorities and filed appropriately (if applicable)? ☐ ☐ ☐ ☐ Informed Consent/HIPAA Authorization Forms Yes No N/A ☐ Not Reviewed Notes Are all versions of the IRB approved informed consent/assent present and filed? ☐ ☐ ☐ ☐ Are all versions of the IRB approved HIPAA Authorization(s) present and filed? ☐ ☐ ☐ ☐ Are all versions of the IRB approved information sheets present and filed (if applicable)? ☐ ☐ ☐ ☐ TIP: Tracking/version history logs are often used to track informed consent versions approved with corresponding IRB submission and a summary of the changes. A template can be found in the . FDA Related Documentation Yes No N/A ☐ Not Reviewed Notes This section is applicable only to studies conducted under an investigator-held IND, IDE, or BLA. Did the PI submit the necessary regulatory application(s) (e.g. IND)? ☐ ☐ ☐ ☐ Are all IND/IDE submissions and supporting materials (if applicable) available? ☐ ☐ ☐ ☐ TIP: It is highly recommended to include a Submission Summary Table with each IND, IDE or BLA. Was the FDA properly notified of amendments and new information? ☐ ☐ ☐ ☐ Have Safety Reports been reviewed and reported as appropriate? ☐ ☐ ☐ ☐ Have all annual reports been submitted in a timely manner? ☐ ☐ ☐ ☐ Is FDA correspondence (including confirmation letters, acknowledgement letters, and reports) on file? ☐ ☐ ☐ ☐ Is a list of studies for which the PI is/was responsible available and up to date (should include title, start and stop dates)? ☐ ☐ ☐ ☐ Note: The list is only applicable in preparation for an external
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? ☐ ☐ ☐ ☐
Is Monitoring Visit correspondence (including confirmation letters, reports) on file? ☐ ☐ ☐ ☐ Do the study files include correspondence related to externally conducted site visits and/or audits (i.e. NIH, FDA, sponsor, etc.)? ☐ ☐ ☐ ☐ Is there a DSMC/DSMB for this study? ☐ ☐ ☐ ☐ 58a. If Yes, are all DSMB reports and recommendations on file? ☐ ☐ ☐ ☐ 58b. If Yes, have all DSMB reports been submitted to the IRB? ☐ ☐ ☐ ☐ Study Conduct Yes No N/A ☐ Not Reviewed Notes Is a Manual of Procedures present? ☐ ☐ ☐ ☐ TIP: A Manual of Procedures (MOP) is a detailed guideline that describes the protocol, required procedures and how they are implemented. The MOP provides additional information to ensure that the study is conducted consistently by all study personnel. Are protocol requirements being followed? ☐ ☐ ☐ ☐ Are all unanticipated problems, noncompliance (deviations/ violations), new information, and SAEs documented and tracked appropriately? ☐ ☐ ☐ ☐ Were applicable reportable events submitted to the IRB and applicable authority(ies) promptly with copies present in the Regulatory File(s) (unanticipated problems, deviations/ violations, noncompliance, AEs, SAEs, etc.)? ☐ ☐ ☐ ☐ Was/Is blinding maintained according to the IRB approved protocol (if applicable)? ☐ ☐ ☐ ☐ Is the Subject Identification Code List (i.e. master list) available? ☐ ☐ ☐ ☐ Is the Subject Screening and Enrollment Log available? ☐ ☐ ☐ ☐ TIP: OnCore users can rely on the CRA Console > Accrual screen to fulfill the Identification Code and Subject Screening and Enrollment Log requirements.
If the study is an investigator-initiated, multicenter study, have all investigative sites been properly notified of relevant safety information? ICH GCP E6: 8.3.18 Have changes in facilities been documented appropriately? ICH GCP E6:.2.3, 4.9.4, 5.18.4(b) 21 CFR: 812.35(b) Is the ClinicalTrials.gov record up to date? Is there reason to believe that the Investigator has, and is continuing to provide appropriate oversight of the study and/or study team? ICH GCP E6: 4.2.4, 4.3 21 CFR: 312.53 (c)(1)(vi)(c), 312.60, 812.43, 812.100, 812.110(b)(c)