Quality Assurance and Monitoring Office
The Quality Assurance and Monitoring (QAM) Office of the UT Southwestern (UTSW) Human Research Protection Program is vital in promoting and maintaining ethical research that is compliant with institutional policies, state and federal regulations, and best practices for protecting human subjects. The QAM Office evaluates and improves human research protections through monitoring, education, and training.
QAM is responsible provides monitoring and audit support. through review and monitoring of the following:
QAM is responsible for reviewing and monitoring human research studies. In addition, the QAM conducts quality assurance reviews of the activities of the Institutional Review Boards and HRPP Department.
Human Research Studies
Studies are chosen from the list of IRB-approved studies conducted at UTSW. Priority is given to studies that involve direct interventions or interactions with research participants and according to the assessed level of risk to participants and the institution. Research is stratified into four groups according to risk. The HRPPO QA team primarily focuses efforts in the higher risk groups (e.g., investigator-initiated, Phase I and II, unapproved drugs or devices, etc.). The HRPPO QA team may also conduct monitoring visits based on the following:
- Complexity of the research
- IRB, HRPP, Office of Compliance, Institutional Official (IO), or Principal Investigator (PI) requests
- Directed “for-cause” reviews triggered by (but not limited to) subject, employee, or external complaints, a whistleblower, or other information that appear to indicate increased risks to subjects or data integrity.
The QAM goal is to review all UTSW studies at least once every 5 years.
UT Southwestern Institutional Review Boards (IRBs)
The IRB must document discussions, decisions, and findings, which is accomplished through the IRB meeting minutes. To ensure compliance with institutional policies and procedures and applicable federal, state, and local regulatory requirements, the HRPPO QA team audits the IRB meeting minutes and IRB records to ensure appropriate determinations were made.
HRPP Office Activities
The HRPPO is responsible for maintaining policies, procedures, and records for all human subjects' research conducted on behalf of UTSW and/or its affiliates. The QA team audits HRPPO records to ensure departmental and institutional policies are followed. Other records may also be reviewed, such as IRB membership records (e.g., rosters, CVs, etc.), HHS federal-wide assurance documentation, IRB Authorization Agreements, and approved study documentation in eIRB (e.g., finalized consents, protocols, letters, etc.).
You must report upcoming audits to the HRPP
The HRPP is required to track and report all external audits. If you are contacted by the FDA or other external entity announcing an upcoming audit, complete this intake form. On the intake form, you may request support from the QAM Office for the audit.
Support for Federal Inspections
The QAM provides support to investigators before, during, and/or after regulatory audits (e.g., FDA).
Prior to the inspection: The QAM will assist you with preparing for the inspection by consulting about the inspection procedures and what to expect, identifying personnel to meet with the auditors, finding a suitable location for the inspection, and review of study materials.
During the inspection: The QAM will be available to meet with the auditors, answer questions raised during the inspection, locate policy or study documents in the IRB/HRPP records, attend the closeout visit with the auditors.
After the inspection: The QAM will assist with development of corrective and preventable actions and responses to any observations identified during the inspection.