Investigators are ultimately responsible for the conduct of a clinical trial per U.S. Food and Drug Administration (FDA) regulations at 21 CFR 56 and per ICH E6(R2) Good Clinical Practice (GCP) guideline. CITI Program offers many courses to help investigators gain knowledge and deepen their skillsets. Start with our foundational training and supplement with a role-based investigator course, and then add one or more of our topic-focused courses (from research design to biosafety).
The following sections highlight relevant courses. More information for each course is available in our catalog.
Human Subjects and Good Clinical Practice
It’s important to begin with foundational training. Our Human Subjects Research (HSR) and Good Clinical Practice (GCP) are a great start!
HSR
Our HSR content provides up-to-date training in human subjects protection. These courses explore the historical development of human subject protections, review ethical principles and issues, and discuss key issues related to subject protections. Learners will gain an understanding of current regulations and guidance.
The Biomedical (Biomed) Comprehensive course includes modules on core topics such as history and ethical principles, IRB review, informed consent, vulnerable populations, HIPAA, conflicts of interest, and recognizing and reporting unanticipated problems. Additional available modules cover a range of topics from humanitarian use devices, cultural competence, advanced issues in consent, working with different populations, community-based research, phase 1 research, clinical trial agreements, public health research, and single IRB review.
GCP
CITI Program has different offerings for basic GCP courses depending on the type of research.
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
- GCP for Clinical Investigations of Devices
- GCP – Social and Behavioral Research Best Practices for Clinical Research
Many of these are mutually recognized by TransCelerate BioPharma so investigators may not need to repeat GCP training for different sponsors or studies.
Investigators
For investigators that are new to this role or that want a refresher, CITI Program offers a Biomedical Principal Investigator (PI) course. This role-based course focuses on the role and responsibilities in conducting an FDA-regulated clinical investigation. It covers supervision, delegation, management, reports, and communication for investigators.
FDA Inspections
For investigators conducting FDA-regulated investigations, it may be helpful to take the FDA Inspections: From Site Preparation to Response course. This course covers what to expect and how to prepare for a regulatory inspection. It reviews FDA 482s, 483s, and warning letters, and provides strategies (such as performing mock inspections and developing CAPA plans).
Information Security
Investigators will commonly process, collect, store, share, and analyze data in research. Our Information Security course provides training on best practices for data and device security. This includes the basics of information security, protecting your computer and devices, safer emailing, and security for off-site work.
Study Design and Development
The Research Study Design course covers scientific inquiry and how to formulate a research question and develop a hypothesis. It also has topic-focused modules exploring different types of research designs as well as their strengths and weaknesses.
Our Protocol Development and Execution course provides a tactical approach to clinical protocol development and implementation. The course includes evidence-based strategies, best practices from field experts, and standard tools to aid the protocol authoring process. It helps investigators go from a research proposal to developing and executing their own protocol, including modules on topics such as data management, subject recruitment and retention, project management, financial management, and others.
Additional Regulatory Requirements
Different regulations and requirements for training may apply depending on which regulations the research is subject to. Following is a selection of courses that satisfy different requirements.
Responsible Conduct of Research (RCR)
RCR training is commonly required, especially by investigators that receive federal funds (such as from the National Institutes of Health or the National Science Foundation). Our RCR training includes a basic and refresher course that covers the norms, regulations, and rules governing the practice of research. This includes topics such as authorship, peer review, plagiarism, and research misconduct.
Conflicts of Interest (COI)
Certain regulations require investigators to be familiar with the Public Health Service (PHS) financial conflicts of interest regulations. The COI Basic course is designed to satisfy training requirements associated with these regulations.
Basic Introduction to Biosafety
The Basic Introduction to Biosafety course provides an introduction to biosafety for researchers who handle Risk Group 1 agents and are working at BSL-1 containments. The NIH and NSF have requirements for researchers to be trained in biosafety, so this course may be a great starting point.
