In an effort to provide investigators with assistance in process improvement, workplace efficiency and clinical research training and development, Baylor Scott & White Research Institute has recently established a Clinical Research Quality Improvement Program.
The Clinical Research Quality Improvement Program is a proactive management resource available to research programs across the Baylor Health Care System. The program provides many resources, including evaluation of current processes to identify areas for quality improvement, development of strategies to enhance efficiencies and in-house monitoring for investigator-initiated or other trials. The goal of the program is to provide a resource to help facilitate high quality clinical research and compliance with applicable local and federal regulations and all applicable standard operating procedures.
The Quality Improvement Program can be a resource to your research program in the following ways:
- Review of current research site procedures and research studies. The review by the quality improvement specialist will help identify mechanisms to increase efficiencies and strengthen compliance. If there are concerns, the specialist can work with the research team to develop and implement an appropriate plan(s) for follow-up, improvement and/or remediation. If requested, the specialist can reevaluate after implementation to foster quality performance.
- Training and mentoring of new Baylor Scott & White Research Institute research personnel. The quality improvement specialist can guide new personnel on their assigned protocols and be a resource for questions and navigation through the clinical research process.
For clinical studies trials for which there is no external or sponsor-provided clinical monitoring, including investigator-initiated studies, the Clinical Research Quality Improvement Program can provide this service. The main areas of monitoring include:
- Test article accountability
- Informed consent
- Adverse event reporting
- Protocol deviations and violations
- Correlation of source documentation with case report forms, as appropriate
- Inspection of the study binder and regulatory documents
The quality improvement specialist can assist investigators in the early stage of protocol development with the creation and implementation of monitoring plans. The specialist also can evaluate an early protocol draft to identify areas of potential regulatory problems and help develop alternate strategies to facilitate regulatory compliance.
If you are interested in learning more about the Clinical Research Quality Improvement Program, taking advantage of the services offered, or requesting assistance with other issues, please contact either Claudia Mattil, Director, Clinical Research, at 214-820-7548 or Kristen Drake, Quality Improvement Specialist, at 214-820-7557.