Evaluating investigator performance of research serves an important function in the protection of human subjects by ensuring investigator compliance with IRB requirements, regulatory requirements, and institutional policy.
Evaluation of investigator performance is best accomplished in a program that includes these activities:
Quality Assurance (QA): Defined as “all those planned and systematic actions that are established to ensure that the trial is performed and data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s)” [ICH1.46]
Monitoring: Defined as “the act of overseeing the progress of a clinical trial, and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and the applicable regulatory requirement(s)”[ICH 1.38]
Auditing: Defined as “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, GCP, and the applicable regulatory requirement(s)” [ICH 1.6].
At the University of Minnesota, there are two primary mechanisms for conducting evaluation of investigator performance in the conduct of human subjects research:
- The Post-Approval Review (PAR) quality assurance function, which reports to the HRPP and Office of the Vice President for Research
- The Clinical Trial Monitoring Service, which reports to the Clinical and Translational Science Institute (CTSI) and the Academic Health Center (AHC)
Post-Approval Review Program
Quality assurance efforts associated with investigator performance are guided by implementing a risk-based strategy typically occur once during the life of a study and involve an independent, systematic evaluation of study process and assessment of compliance.
The PAR program takes a collaborative review approach with researchers, key study personnel, other supporting institutional programs, and internal/external entities toward a common goal of protecting human research subjects.
Monitoring Report Requirements:
Effective October 1, 2017, written reports of study monitors will require central filing with the Post Approval Review (PAR) program of the HRPP and no longer require mandatory submission to the IRB. This change is being carried out in light of the full migration of all clinical research protocols to ETHOS and aligns with planned global changes described in the Advancing Human Research Protections Final Monitoring Report.
Investigators are required to submit promptly reportable events to the IRB within five business days of discovery of the event. Occasionally, such events are identified during clinical monitoring and, as such, must be reported to the IRB accordingly.
To submit monitoring reports to PAR, complete this form: QA Central File for Clinical Trial Monitoring Reports Self-Assessment. You will be asked to attach the monitoring report to the form.
Clinical Trial Monitoring Service
The Clinical Trial Monitoring Service (under the guidance of AHC) performs clinical trial monitoring, defined in E6 GCP Consolidated Guidance, as: 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, GCP, and the applicable regulatory requirement(s).
In contrast to the “moment in time” QA reviews conducted by the PAR program, clinical trial monitoring is an ongoing assessment through the life of the study.
Currently, CTSI maintains a regulatory group in its Research Services division that provides monitoring services over the life of the study where monitoring is required by the FDA or NIH, or is requested by the study sponsor-investigator.
Consistent with 5.18.1 of E6 GCP Consolidated Guidance, the main purpose of monitoring activities performed by the Clinical Trial Monitoring Service is to:
Ensure the rights and well-being of human subjects are protected
Reported trial data are accurate, complete, and verifiable from source documents
The conduct of the trial is in compliance with the currently approved protocol as well as with GCP and other applicable regulatory requirements
The CTSI monitoring group, as resources allow, will initiate a process where every non-industry sponsored biomedical study in the School of Medicine that is identified as greater than minimal risk is included in the monitoring program, as described above.
Biomedical studies sponsored by industry are not included, since the industry sponsor already provides this service directly. However, a small number of industry-sponsored studies conducted through the School of Medicine will be locally reviewed annually to provide awareness and understanding of the industry-monitored studies.