Clinical Trials Brown Bag
February 18, 2016. Clinical trials from the perspective of an independent research site. Presented by Dr. Jeff Kingsley, CEO, Southwest Regional Research Group
Clinical Trials Resources for Investigators and Staff
The Clinical Trials Resource Group serves as a repository of knowledge regarding clinical research regulations and processes. This knowledge guides development of educational materials and tools for faculty and staff to facilitate compliance with regulations. We also provides hands-on assistance on selected projects.
It is important to clarify that the Clinical Trials Resource Group does not:
- Assume the PI’s responsibility for study conduct and compliance with applicable regulations and requirements;
- Ensure safety of research study subjects or data integrity;
- Assume responsibility for results of any FDA or internal audits;
- Assume responsibility for billing compliance of individual studies, financial solvency of trials, correction of claims, or resolution of billing disputes on studies.
Regulatory Compliance. CTSC supports investigators, the IRB, and the Office of Research Compliance and Integrity (RCI) by providing training and consulting services. Consulting services are recharged where indicated (see rates below).
- Good Clinical Practice (GCP) Education – Supports CITI training by providing in depth training on implementation of GCP principles at UC Davis.
- Study Start-up and Study Management - Analyze protocol, prepare and negotiate budgets, develop Coverage Analysis, IRB documents and study logistics; manage the study until completion (recharged)
- Preparation of IRB and FDA documentation – Support for individual projects as requested (recharged).
- Coverage Analysis and Internal Budgets; Budget negotiation with sponsors (recharged)
- Coordinator for hire - Support for individual projects as requested(recharged).
- Regulatory Oversight of Department coordinators to ensure study excellence (recharged).
- Clinical Research Coordinator Mentoring of new Department coordinators to identify and fill knowledge/experience gaps per CTSC SOP#3 (recharged)
- Study Monitoring – Support for individual projects as requested. CTSC does not assume responsibility for quality assurance on all investigator-initiated studies, only for the quality of the contract work (recharged).
- Internal Audits – Help resolve RCI findings on projects, as requested (recharged).
- FDA audits – Help prepare for the FDA audits, as requested (recharged).
- IND/IDE – Provide tools, training, information or support as requested (recharged).
- Clinicaltrials.gov – Opening accounts for individual researchers, as requested, and education on ct.gov principles. CTCS does not assume responsibility for technical support or fulfillment of ct.gov requirements by individual investigators.
Clinical Research Billing (CRB). CTSC stays abreast of new regulations in the area and continuously incorporates these into training materials and tools. We create tools, templates, quality training materials, and provide consulting on processes that involve clinical research billing. We provide Coverage Analysis support for individual studies, as requested.
- CRB Education – Provide training in the form of workshops and materials on the web.
- Coverage Analysis document preparation – Support for individual projects as requested.
- CRB Process improvement – Participate in technical implementation of HS Compliance requirements (i.e., Bridge, EMR research functionalities) by guiding IT with accurate information to develop solutions.
Clinical Research Process Improvement. We create training and tools (i.e.,Clinical Research Guidebook, Process Maps and SOPs) to guide researchers through the clinical research process at UC Davis. We generate metrics for evaluation of the process for decision-making by the Dean’s office. We provide Lean consulting on selected projects, however, it is a Department responsibility to implement and oversee the improvements suggested by the CTSC Lean consultants.