The Research Compliance and Quality Assurance Program (RCQA) supports researchers to ensure compliance with the regulations and legislation surrounding research practices, focusing on the continued development of quality clinical research at HHSC. The program helps researchers with investigator-initiated trials, confirming that their research projects are conducted according to the standards set forth by the legal representative agencies and globally-accepted research guidelines. Working within an established framework and embracing a risk-based approach, the program provides researchers with internal audit services and educational tools to ensure adherence to clinical research regulations.
The strategic focus of RCQA is “creating a collaborative research environment where compliance and quality assurance are wove in research operations and practices.”
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Focusing on investigator-initiated trials, the Research Compliance and Quality Assurance Program (RCQA) offers the following services:
The Research Compliance and Quality Assurance Program provides information and updates on a wide variety of regulatory issues. The program helps facilitate training modules that are current, accurate, comprehensible and promote the uptake and retention of the material presented. The program team will evaluate and determine the need for additional regulatory training opportunities.
The RCQA team will help create new training modules as deemed necessary in order to provide HHSC Research staff with the education needed to apply the relevant regulations to their studies. The team will also utilize the outcome of internal and external audits and systematically improve the HHS research process by establishing necessary Standard Operating Procedures. Facilitating discussions with all stakeholders, the team will help identify and address barriers to compliance and help identify a process that is robust and efficient.
The RCQA Regulatory Training and SOP Program offers the following services:
This part of the program will provide an independent review of research study processes, in order to ascertain compliance with regulatory requirements and internal Standard Operating Procedures. The RCQA will provide researchers with internal review and audit services for investigator-initiated trials as well as educational tools to help investigators and their research teams to better understand clinical research regulations and the important of research compliance.
The compliance and quality assurance team supports research and their staff with study compliance to all federal legislation and clinical research regulations. They will work closely with investigators and their delegates throughout the review process, provide essential resources, and offer insight on possible improvements to their research conduct. The review will consist of an evaluation of regulatory documents, research records, and research facilities. The team will also support internal efforts to prepare for external audit/inspection.
The RCQA Regulatory Review and Assessment Program includes the following services:
The risk based monitoring approach will verify the data at high risk sites/study based on triggered events and other pre-defined clinical events in a study. The quality of the trial data will be improved by identifying, assessing, monitoring and mitigating risks. This is a service that will be provided to investigators, upon request, as an outsourced service tailored to the needs and complexity of the study.
A risk based morning plan includes:
Regulatory Training, Education and Standard Operating Procedures
Regulatory Review and Assessment
Risk Based Monitoring of Clinical Trials