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Clinical Research Support Office/CRSO

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v) Auditing and Monitoring

All investigators are encouraged to conduct internal reviews of study conduct and research documentation as a routine quality assurance activity. Investigators are also subject to auditing and monitoring of protocol activities. Routine reviews of study conduct 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.  The CRSO engages the assistance of Hospital departments dedicated to QA and routine review, such as Hospital Information Systems (HIS), and the Office of Regulatory Affairs, in monitoring and auditing clerical aspects of research conduct. All monitoring and audit reports are reviewed by the CRO.

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).  

The CRSO conducts audits of active research protocols for quality assurance and training purposes. Protocols are selected for audit based on 1) Protocol Risk/Complexity, 2) Investigator Experience, 3) Investigator Record, 4) Presence/Absence of an IND or other regulatory requirements  and/or 5) Upon notification of a possible concern about research conduct. Audits are conducted according to written SOPs,

  •  Not-for-Cause Audits: The CRSO conducts not-for-cause audits of studies to ensure that they are administered in a way to protect research participants and in compliance with applicable standards. The audits are conducted by CRSO staff or external auditors who review study documentation and prepare a report. The PI is required to submit the report to the IRB. If any issues are found, the PI will be required to submit a plan of correction to the IRB and documentation of implementation of the corrections. Results of the audit are reported at a scheduled meeting of the IRB and included in the minutes.
  • For-Cause Audits: Where there is probable cause for concern, the IRB will request a for-cause audit of an investigator’s study by the CRSO. Probable cause may include irregularities or inconsistencies that present themselves upon continuing review of a study, or information that has come to the attention of the IRB or the CRO. The PI will be required to submit and adhere to a plan of correction that will be reflected in the IRB minutes.
  • Early Audits: The CRSO conducts routine, Not-For-Cause Early Audits within the first few months of the start of a study. Studies with newly formed research teams or involving new procedures, or complex workflow may be chosen to assure that safety and compliance have been optimized. 

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 and applies to the records of all participants, whereas auditing is usually performed at pre-specified times unless there is a reason to conduct an audit earlier, and samples 10-15% of participant records.

The FDA requires the Sponsors of FDA-regulated studies to conduct regular monitoring. Commercial Sponsors contract with commercial monitors to provide these services.  Investigator-Sponsors are encouraged to arrange for external monitoring and to secure appropriate funding when establishing budgets and writing grants. Investigators who arrange for the monitoring of their FDA-regulated studies will be required to follow written procedures (SOPs) for monitoring. The CRSO staff can assist investigators in developing monitoring SOPs for their protocols.  

Issues of non-compliance as judged by Hospital, IRB, Human Research Protection Program, or other University policies will be referred to the Office of Regulatory Affairs, the Medical Staff Executive Committee, and the IRB or University for corrective action, or if necessary, for disciplinary action in alignment with policy. 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.


Site Map Investigators Log-inv) Auditing and MonitoringAll investigators are encouraged to conduct internal reviews of study conduct and research documentation as a routine quality assurance activ