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? ☐ Not Study Conduct Yes No N/A Notes Reviewed 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.
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.
Self-AuditToolRegulatoryFileReview-2016_11_11_clean.docx