Post Approval Review Program
The Post Approval Review Quality Assurance and Quality Improvement Program (PAR QA/QI) is a component of the HRPP that evaluates regulatory compliance of investigators and improves investigator performance through systematic and independent examination of human research activities and documents. QA efforts are guided by a risk-based strategy.
The PAR QA/QI program also evaluates IRB performance as required by the Association for the Accreditation of Human Research Programs (AAHRPP) and includes methods to assess the quality, effectiveness, and efficiency of the HRPP.
PAR QA/QI Program has the responsibility to:
- Conduct QA/QI assessments of investigator compliance
- Conduct direct observation of the informed consent process
- Conduct assessments to verify PI compliance with IRB-directed corrective actions
- Conduct QA/QI assessments of IRB performance
- Report IRB UPIRTSO, Serious or Continuing Non-Compliance, and Suspensions and Terminations determinations, to department leadership, institutional officials, and regulatory agencies
Clinical Trial Monitoring Service
The Clinical Trial Monitoring Service (under the auspices of the Academic Health Center) 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 (SOPs), GCP, and the applicable regulatory requirements. 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, the 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.
Health Information Privacy & Compliance
The Health Information Privacy and Compliance Office (HIPCO) is responsible for ensuring that individually identifiable health information is handled appropriately across the entire University.
Department of Audits
The Department of Audits provides a wide array of services to the University, primarily through the conduct of financial, operational, compliance, and information system audits. The types of work performed extend to human research conducted by the University, and include:
- Risk-based college and departmental audits
- Risk-based University process audits
- Risk-based information technology audits
- Investigations of financial or operational misconduct
- Special projects requested by University management
- Consulting on new systems, processes, or others areas of risk
Office of Institutional Compliance
The Office of Institutional Compliance (OIC) is responsible for four institutional program areas that have an impact on human research: compliance, conflicts of interest, policies, and the University president’s delegations of authority.
Research Compliance Office
The Research Compliance Office (RCO) supports the research community by investigating research compliance concerns, overseeing research ethics and compliance education, and managing compliance programs across the University related to financial controls and the protection of humans and animals involved in research.
Office of the General Counsel
Legal counsel has the responsibility to:
- Provide advice upon request to the institutional official, IRB, and other individuals involved with the HRPP.
- Determine whether someone is acting as an agent of the University
- Determine who meets the definition of “legally authorized representative” and “children” when human research is conducted in jurisdictions not covered by policies and procedures
- Resolve conflicts among applicable laws