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.
- Investigator Training – On site regulatory start-up training for investigator-initiated studies.
- Complete Study Start-up - Analyze protocol, prepare and negotiate budgets, develop Coverage Analysis, IRB documents and study logistics; up to Site Initiation Visit (recharged)
- Preparation of IRB documentation – Support for individual projects as requested (recharged).
- Coordinator for hire - Support for individual projects as requested(recharged). Selection is based on resource availability and limited to allow access by a broad range of constituents.
- 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.
All prices include benefits
If CTSC performs the complete study start-up as described above, then CTSC team will be compensated from the start-up funds negotiated in the industry budget. Departments are not charged separately for hours of work
K12, T32 or other institutionally recognized scholar/ training award*
Up to 90% CTSC subsidy (for additional financial support, see *Note)
Regulatory Analyst: $6.80
NIH, NSF, DoD, VA, Foundations, other government and non-profit sponsors
Up to 25% CTSC subsidy (for additional financial support, see *Note)
Regulatory Analyst: $51
Up to 50% CTSC subsidy (for additional financial support, see *Note)
Regulatory Analyst: $34/hr
*New Investigators, those who have not yet competed successfully for a substantial NIH research grant but may have received a small grant (R03) or an Exploratory, Developmental Research Grant Award (R21) and Junior Investigators (within 10 years of completing a terminal research degree, medical residency, or equivalent) may request additional financial support. CTSC management will consider requests based on the scientific merit of the project.