When preparing to start your clinical research project at UC Davis, you need to be aware of mandatory and optional training offered by the different administrative offices.
This training is mandatory for anyone participating in human subjects research. UC Davis employs the Collaborative Institutional Training Initiative (CITI) program—a web based training program to satisfy the training requirements for all personnel conducting human subject research at UC Davis. CITI offers two versions of the Basic Human Research Training course: one for Biomedical Investigators and one for Social & Behavioral Investigators. However, IRB recommends Social & Behavioral Module offered via lms.ucdavis.edu. An additional module on Good Clinical Practice (GCP) is required for individuals conducting clinical trials with the FDA-regulated drugs or devices. Certification is valid for 3 years.
Clinical Epidemiology and Study Design Course
This intensive 34-hour course in clinical research methods will cover issued related to developing a research question, synthesizing the literature, study design, questionnaire design, data collection, data management, sample size planning, data analysis, presentation and publication. It is designed to meet the requirements for research methods training in most ACGME-accredited fellowship training programs.
The principal instructors are Drs. Patrick Romano, Eleanor Bimla Schwarz, and Laurel Beckett. The course is designed for new faculty, fellows, nurses, and interested persons beginning or considering a career in conducting or interpreting clinical research.
Short Syllabus for 2017
IRB Training and Investigator Manual
New Submitter Training is conducted by the IRB Administrations Outreach, Training and Education team. This orientation provides detailed training on the ethical principles of human research, an explanation of the researcher’s primary responsibility for protecting research subjects and for complying with all applicable provisions of institutional, state and federal laws. It provides an explanation of the different levels of IRB review and describes the processes for IRB submissions.
In addition, the UC Davis Investigator Manual, and IRB Standard Operating Procedures are available as guides related to the conduct of Human Research that are specific to UC Davis. The Investigator Manual discusses the mechanics of working with the IRB and Human Research Protection Program.
Contact: Nicole Walters, IRB Education
This excellent additional educational resource is available at no charge to all UC Davis employees. These webinars match the CTSA Clinical Research Competency domains. Self-paced study modules and webinar replays - use them for self-study continuous education units towards your ACRP or SoCRA certification. Variety of topics
Contact Kate Marusina, PhD, MBA, Director, Clinical Trials Office, to be added to the eLearning system
Clinical Trials Education and Training Program
The UC Davis Clinical Trials Office (CTO) administers the CTSC Education and Training Program. CTSA Consortium is working towards achieving a standardized training platform in Good Clinical Practices and the necessary means to disseminate it across all consortium sites. UC Davis CTSC aligns the educational offerings to match Competency Domains adopted by the CTSA Consortium and outlined in the COAPCR publication "Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional," by S.A. Sonstein et al. The UC Davis curriculum delivers practical knowledge for implementation of clinical research regulations specifically at UC Davis and is supplemental to the IRB Training.
- CRC 1.0 is Fundamentals Training for junior specialists and new coordinators, and happens several times per year.
- CRC 2.0 is in-depth training on UC Davis processes and procedures occurs monthly.
- CRC 3.0 is the yearly Leadership and Professionalism Conference and Award Ceremony.
- The CTSC also works together with SoCRA Northern California to deliver monthly web-based seminars on a variety of global topics in clinical research.
Contact Kate Marusina, PhD, MBA, Director, Clinical Trials Office, to be added to the listserv.
CRC Mentoring Program
The CTO one-on-one CRC Mentoring Program supplements the Department/Center-based training for the new staff. Participation is voluntary and is at the discretion of the mentee's home Departments/ORUs. The program's goal is to provide individual personalized mentoring based on the mentee’s level of skills, knowledge and experience. Selection of staff for the program 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. More details can be found in CTSC Clinical Research SOP#3.
Contact: Virina De Jesus, Clinical Research Supervisor, CTO
Financial Conflict of Interest (FCoI) training
On August 24, 2012, new and more stringent rules for the disclosure of financial interests took effect for all research sponsored by the Public Health Service (PHS), including the National Institutes of Health (NIH). The new rules also apply to several non-federal sponsors, including the American Cancer Society and the American Heart Association. Click here for the list of agencies and entities (“covered entity”) that have adopted the PHS financial conflict of interest (FCOI) and disclosure rules.
The FCOI rules apply to all “investigators” who engage in any research funded by a covered agency. “Investigators” are defined by PHS to include principal investigators and any other individual who, regardless of title or position, have responsibility for the design, conduct, or reporting of such covered research. This includes, for example, any graduate student or post-doctoral fellow who meets the definition of investigator. Each investigator must separately submit a financial disclosure statement to the UC Davis’ Research Compliance and Integrity. The Disclosure must identify financial interests of the investigator, spouses/ registered domestic partners, and dependent children that exceed the thresholds set by PHS and that relate to any of the investigator’s institutional responsibilities. Disclosures must be made at the time of application for funding from a covered agency; annually; and within 30 days after acquiring or discovering a financial interest that must be disclosed as defined by PHS.
All investigators who are engaged in any research funded by a covered entity must complete mandatory "UC Compliance and Conflict of Interest for Researchers" eLearning training (COIR-DA-ECO).
Dangerous Goods Shipping for Infectious Substances and Dry Ice
These emodules are available through UC Davis LMS system
- DOT (4 modules)
- IATA (5 modules)
- Guide to shipping Dry Ice (DAC-DRY-ICE-SAFSVC )
- Hazardous Materials Shipping (DACS-UCLOL0003-SAFSVC)
Blood Borne Pathogens
available through UC Davis LMS
Medical Waste Management
available through UC Davis LMS
Lab Safety Fundamentals
UC Laboratory Safety Fundamentals ( https://safetyservices.ucdavis.edu/training/uc-laboratory-safety-fundamentals) - Not required of clinical research coordinators as of 10/2018
Epic® EMR Clinical Research Management
UC Davis Health Compliance requires all Principal Investigators and Coordinators to complete the mandatory Epic Research Management eLearning courses in LMS. These courses describe the basics of maintaining the study in Electronic Medical Records, linking patients, their visits and procedures with research studies, and performing reviews of research-related charges.
- Billing Review Process #09234
- Research Study Management #08074
- Investigator Research Management Requirements #08084
Clinical Research Budgeting and Billing Course
The course (LMS# 09155) builds on the principles for clinical research billing provided by the ACRP eLearning Module "Managing Billing Compliance Risk: Navigating Medicare in Clinical Trials." The regulatory environment related to clinical research billing is complex and compliance with guidelines is a key part of every research study. This training program provides an orientation to the financial and administrative infrastructure that supports clinical research billing across UC Davis Health.
Topics covered in the course:
- 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
All study team members are encouraged to take this orientation program to prepare for this important process.
Contact: Suzan Bruce, Research Coder, Clinical trials Office
This eLearning Course (DAHS-PSID16) provides basic background knowledge of Investigational Drug Services. Highlights key requirements for dispensing investigational substances on a UCDMC IRB Approved Protocol.