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v) Monitoring

An audit consists of "a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s) (GCP, ICH, 1.6) .

Monitoring, a more general term, refers to the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s) (GCP, ICH, 1.38 Monitoring).

In general, monitoring is conducted continuously during a protocol, whereas auditing is usually performed at pre-specified times unless there is a reason to conduct an audit earlier.

Monitoring activities will be coordinated from the CRSO. Investigator-Sponsors will also be encouraged to consider external monitoring resources and secure appropriate funding when establishing budgets and writing grants. Written Monitoring Standard Operating Procedures will guide the conduct of audits of IND-related protocols, (conducted by the Program of IND Assistance, and non-IND containing research protocols will be monitored and audited by CRSO Clinical Research Monitors. Investigators who conduct their own monitoring will be required to follow written procedures for monitoring according to policy. The CRSO may engage the assistance of the departments dedicated to QA and routine review, such as HIS, and the Office of Regulatory Affairs in monitoring and auditing clerical aspects of research conduct. All monitoring and audit reports will be reviewed by the CRO.

Routine monitoring reviews are for performance improvement and compliance purposes, and are intended to support and advise the investigator as well as to protect subject safety and data integrity. Written procedures, federal regulations, and harmonized IRB and CRSO policy will determine when monitoring or audit results are reported to the IRB, or by the IRB to other agencies.

Issues of non-compliance as judged by Hospital, IRB, and University policies will be referred to the Office of Regulatory Affairs, the Medical Staff Executive Committee, and the IRB for corrective action, or if necessary, for disciplinary action. The close coordination of policies and SOPs across departments is critical to assuring that educational content, monitoring standards, and plans for corrective action are all aligned and harmonized.

Voluntary and not-for-cause audits will be performed on a rotating schedule, with the frequency based on a systematic assessment of 1) Protocol Risk/Complexity, 2) Investigator Experience, 3) Investigator Record, and 4) Presence/Absence of an IND or other regulatory requirements. Monitoring visits and audits will guided by written SOPs, and will be conducted using a structured tool, based on a template, customized by the CRSO at the time of protocol approval by the IRB, and overseen by the CRSO monitoring staff. The Monitoring activities can be separated into those that are largely clerical, and thus can be managed by HIS-like functions or automated by the Clinical research system (e.g., dating of forms, presence/absence/completion of forms) and those requiring medical review and clinical research monitoring expertise. Such additional forms of oversight include the CRSO review of compliance with aspects of GCP, or evaluation and reporting of adverse events. The CRSO Monitors will have significant experience in the conduct of clinical research, and at least 3 years of experience in monitoring academic and industry-sponsored research. They will also be experienced and effective teachers and participate in the teaching of GCP to the professional research staff on a regular basis.