Clinical Research Education Program 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.
CTSC Clinical Trials Office Clinical Research Education Program flyer (PDF)
Investigator Clinical Research Implementation Course
This hybrid Spring-quarter, 10-week, 100-hour, 3.0 credit hour graduate level course will be a step-by-step examination of the process of constructing and implementing a formal translational clinical research protocol at an academic medical center. It is in line with competency domains set forth in the Joint Task Force for Clinical Trial Competency Revisions Workgroup’s Harmonized Core Competency Framework for the Clinical Research Professional. Emphasis will be placed on evaluation of study feasibility, design of the formal clinical study protocol suitable for Institutional Review Board (IRB) review, and use of appropriate institutional resources to conduct human clinical trials. Applicants will be selected by the CTSC selection committee.
The UC Davis CTSC offers ACRP e-learning programs recognized by (Transcelerate BioPharma), including a wide variety of training topics on essential components of quality clinical research, plus multiple options for completing required GCP (Good Clinical Practice) training.
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.
Clinical Research Coordinator (CRC) Foundations Training Program
The Clinical Research Coordinator Foundations Training Program offers an exciting, first-of-its-kind opportunity to participate in a course that will provide the foundational learning for the roles and responsibilities of a CRC at UC Davis Health. This is a 16-week, hybrid model course including in-person lectures, self-study eLearning, interactive activities, shadowing, and field trip opportunities to multiple UC Davis Health units directly involved in the daily work for a CRC. Please note that the current pandemic situation requires COVID-19 vaccine status be completed prior to course enrollment.
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Limited Clinical Skills Program
This program, provided by Sierra College Nursing Program through the CTSC, is aligned with the UC Davis Health Policy 1505 “Unlicensed Staff Performing Services for Research,” and developed jointly by CTSC and Sierra College. The training covers phlebotomy, vitals, and EKG lead placement. Phlebotomy is practiced on artificial arms first, then on each other. Each attendee must be present for three in-person classes at Sierra College (Rocklin Campus), complete extensive online homework and pass the competency tests to gain the Certificate of Completion. Successful completion allows the certified staff to practice limited clinical skills for research purposes only, at any UC Davis Health clinic and at the hospital. This is not a medical assisting or CPT (Certified Phlebotomy Tech) certification. The CTSC is subsidizing the training, reducing the cost per person to $400, all inclusive. CTSC will invoice the departments upon completion. If an attendee is unable to complete all classes (*with the exception of an emergency), your department will be billed the full cost of $800. Please be sure you or your candidate(s) can attend the full session before committing.
How to sign up:
Research department managers may place their staff on the waitlist for a future training session by contacting Tara Lynn Johnson via email email@example.com. Please include the attendee's name, department/role, and email address. All inquiries will be placed on a waitlist to be offered placement in a future cohort.
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 firstname.lastname@example.org
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 email@example.com.
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.
A list of online training courses is provided by the Laboratory Health and Safety unit for Davis and Sacramento campuses. The Laboratory Health and Safety unit sets standards for research safety management as well as individual laboratory safety programs and activities.