Quality Assurance Program
The Quality Assurance (QA) program evaluates investigator and Institutional Review Board (IRB) compliance with organizational policies, procedures, and applicable laws and regulations for human research activities conducted or overseen by the University of Minnesota.
The QA program includes the following functions:
- Evaluating Investigator Performance
- Evaluating IRB Performance
- Responding to Complaints, Concerns, and Questions
- Reporting on the Work of the HRPP through Metrics
The role of the QA program is distinct from other compliance units within the University. While the QA program uses the term “audit” to describe its evaluations of investigator and IRB performance, this work is not the same as the audits conducted by the Office of Internal Audit and in no way reflects any involvement of that office.
When evaluating investigator performance, the QA program follows International Conference on Harmonisation Good Clinical Practices E6 (GCP) guidance in defining “quality assurance” 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)” (ICH GCP 1.46).
The QA program takes a collaborative and educational approach with investigators and study team members toward the common goal of ensuring responsible conduct of human research. The audit process, including checklists and reports, is transparent to researchers. The checklists used are available in the IRB Toolkit Library, and draft audit reports are provided to researchers for review prior to submission to the IRB. Final audit reports are submitted to the IRB for acknowledgement or further action. Results of investigator performance evaluations are integrated into education, training, and quality improvement activities throughout the University.
Evaluation of investigator performance is accomplished via the following processes:
- Human research audits (routine and for-cause)
- Investigator self-assessments
- Central file for clinical trial monitoring reports
Human Research Audits
Good Clinical Practice (GCP) defines audits 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 GCP 1.6).
The QA program conducts routine and for-cause audits in alignment with the above definition, as applicable.
Identification and selection of IRB-approved studies for routine audits is based on risk attributes. Generally, a routine audit is likely to occur only once during the life of a study. Examples of risk attributes include:
- FDA-regulated IND and IDE studies
- Studies that enroll vulnerable populations
- Investigators with serious and/or continuing non-compliance in the last three years
For-cause audits of IRB-approved studies are conducted in response to an identified concern (e.g., complaint, information, or event). For-cause audits may be requested by the IRB, the institutional official or designee, or the Human Research Protection Program (HRPP) executive director. Examples of reasons that may lead to a for-cause audit include:
- An allegation of non-compliance
- Suspension or termination of IRB approval
- Request to verify investigator compliance with a corrective and preventive action plan
Self-assessment tools and processes may be created for investigators to evaluate and report on their own performance and compliance with research organizational policies, procedures, and applicable laws. Self-assessments may be implemented to address a specific, system-wide concern. Examples of self-assessments include:
- Compliance with a conflict management plan
- Compliance of exempt category 4 research with collection of existing data only
- Compliance with cessation of study activity after IRB approval has expired
Central File for Clinical Trial Monitoring Reports
The QA Central File for Clinical Trial Monitoring Reports was implemented to collect and track clinical trial monitoring findings. The central file includes internal and external monitoring reports, such as those provided by CTSI, sponsors, or contract research organizations (CROs). Clinical trial monitoring reports can serve as an early warning system for institutional leadership about investigator performance issues. The QA program summarizes monitoring findings to report on key compliance areas.
All clinical trial monitoring reports must be submitted within two weeks of receipt. Submit monitoring reports here.
Note: Occasionally, promptly reportable events are identified during clinical trial monitoring. The investigator must report such events to the IRB within five business days of discovery of the event. For more information, see Investigator Manual, “What should be reported promptly to the University of Minnesota IRB?”
The QA program evaluates the IRB performance as required by the Association for the Accreditation of Human Research Protection Programs’ (AAHRPP) Accreditation Standards.
Evaluation includes assessment of the quality, effectiveness, and efficiency of the HRPP against the following standards:
- The structure and composition of the IRB are appropriate to the amount and nature of the research reviewed and in accordance with requirements of applicable laws, regulations, codes, and guidance (AAHRPP Standard II-1).
- The IRB evaluates each research protocol or plan to ensure the protection of participants (AAHRPP Standard II-2).
- The IRB approves each research protocol or plan according to criteria based on applicable laws, regulations, codes, and guidance (AAHRPP Standard II-3).
- The IRB provides additional protections for individuals who are vulnerable to coercion or undue influence and participate in research (AAHRPP Standard II-4).
- The IRB maintains documentation of its activities (AAHRPP Standard II-5).
The HRPP is concerned about the safety, rights, and welfare of all individuals participating in research at the University of Minnesota and its affiliated sites. All concerns and complaints are taken seriously.
QA staff members promptly respond to all complaints, concerns, and questions received. Items can be submitted via the Research Subjects Advocate Line and/or the Human Research Protection Program Feedback form.
Complaints or concerns may be submitted directly to the HRPP by anyone, including research participants, family members and representatives, and study team members. The HRPP is required to respond to all concerns and complaints received. QA staff will attempt to resolve minor items with the reporter, if appropriate. This may include referring the reporter to the study team.
If an item cannot be resolved easily, additional actions will be taken. This often includes requesting that the researcher report the item to the IRB as Reportable New Information (RNI). When a complaint includes issues outside of the scope of the HRPP, QA staff will forward the complaint to the appropriate University offices or authorities.
The HRPP publishes metrics gathered by the QA staff members. These metrics are an important element of tracking and monitoring IRB and QA performance and implementing quality improvement initiatives. HRPP measuring and reporting is conducted in accordance with key program initiatives and with the following Association for the AAHRPP standard:
- The organization measures and improves, when necessary, compliance with organizational policies and procedures and applicable laws, regulations, codes, and guidance. The organization also measures and improves, when necessary, the quality, effectiveness, and efficiency of the Human Research Protection Program (Standard I-5).