Education and Training Resources
The following eight Core Competencies for Clinical and Translational Research, targeting principal investigators and clinical research coordinators, were developed by the Enhancing Clinical Research Professionals’ Training and Qualifications project.
- Scientific concepts and research design
- Ethical and participant safety considerations
- Medicines development and regulation
- Clinical trial operations
- Study and site management
- Data management and informatics
- Leadership and professionalism
- Communication and teamwork
The UC Davis CTSC Clinical Research Education Program is created in line with the NCATS Clinical and Translational Science Awards competency domains and targeted for principal investigators and clinical research coordinators/staff. These modular courses are designed to enhance clinical research competencies at UC Davis. All classes are presented in a virtual setting online via Zoom and are open to UC Davis employees only.
For current registration information and course detail, please visit the CTSC Event Calendar. The education program consists of three tracks: Regulatory, Operations and Electronic Medical Record (EMR).
Regulatory (REG) covers topics including IRB requirements and submissions, informed consent, ethical and participant safety considerations, regulatory documents, and deviations and reportable events.
Operations (CRC) covers topics related to study and site management. The topics include site and study operations, organization and efficiency best practices, risk management, safety reporting, study feasibility, documentation of research, management of clinicaltrials.gov, development, and negotiation of contracts and agreements, building internal and external budgets, sponsor negotiations, financial management, research billing, study drug management, and participant recruitment and retention.
Electronic Medical Record (EMR) encompasses administration of a research study record in Epic EMR, associating patients, encounters, and procedures with the research record, and tracking and reviewing research charges in the billing report. In addition, these courses will cover the EMR basics, including efficiency features and special topics: reporting of adverse events, contraindicated medicine warnings, alerts, reports, and recruitment via MyChart.
For questions about the CTSC Clinical Research Education program, contact Tara Lynn Johnson, Clinical Research Education Program Coordinator, at hs-CTOeducation@ucdavis.edu.
Collaborative Institutional Training Initiative (CITI) offers two human subject research protection courses, one for researchers conducting biomedical research and one for researchers conducting social and behavioral research. Choose the course that applies to the majority of your research. Visit the UC Davis CITI information section of the UC Davis Office of Research website regarding required training.
The regulatory environment related to clinical research billing (CRB) is complex, and compliance with relevant agency guidelines is a key part of every research study. The UC Davis Health CRB training program includes:
- ACRP eLearning module ("Managing Billing Compliance Risk: Navigating Medicare in Clinical Trials"), and
- UC Learning Center course #09155 ("Clinical Research Budgeting and Billing"), which builds on the principles for clinical research billing provided by the ACRP module.
By the end of this program, you will be able to:
- Identify steps of the research billing process
- Determine what the study team must do to ensure compliance
- Learn how others support you to ensure research billing compliance
Topics covered in the program:
- Correctly routing charges for hospital and clinic procedures and services
- Coverage Analysis in the Bridge
- EMR Research Study File (RSH) in Epic
- Association of the patient to the study
- Association of Orders and Encounters to the study
- Completion of Billing Review
- Verification of charges using Reports2Web billing statements
Questions? Contact Suzan Bruce, PRA IV, at email@example.com
The CTSC CRC Mentoring Program is a one-on-one mentoring program for UC Davis Clinical Research Coordinators and other research staff in a CRC functional role. Priority is given to those participating in FDA-regulated clinical trials with drugs, devices, or dietary supplements. The program is provided for a maximum of 10 hours of face-to-face training with a CTSC mentor. Department funding is required for the trainee to enter the program. A flat fee of $1,000 is charged at the entry into the program. This service is initiated upon request from a home department.
Clinical research SOPs (Standard Operating Procedures) are maintained by the CTSC Clinical Trials Office.
SOCRA (Society of Clinical Research Associates)/CTSC brown bags provide an opportunity to learn about new and exciting developments in clinical research around the world. These events are open to our clinical research colleagues from the Sacramento area and beyond. Attendees may be eligible for a CTSC certificate of attendance and SOCRA CEUs.
For more information about SOCRA, contact Brent Williamson, Associate Executive Director-SOCRA, at firstname.lastname@example.org.
The UC Davis Clinical Research Guidebook is a compendium of UC Davis processes and administrative procedures available in an online format. The Guidebook follows clinical research process maps and provides step-by-step assistance in an easy-to-follow, at-a-glance format. A supplemental checklist bridges the Guidebook and process maps to serve as a tool for those who wish to track their process through a study.