Course 1: Fundamentals of Clinical Research
August 19 – October 13, 2024
In this introductory course, trainees will be given a comprehensive overview of the clinical research process and related concepts, including the fascinating history of clinical research and the decisive events that shaped the standardization of research conduct and human subjects protections as we know them today. They will also explore the drug development process, types of study design, research sites, team roles, and relevant terminology. Additional topics will include the regulations and guidance governing the conduct of clinical research, the ethical issues associated with human subjects research, and the global Good Clinical Practice standards. For context and real-world application, trainees will delve into case studies to examine ethical issues related to informed consent and Institutional Review Board approval.
By the end of Course 1, trainees will be able to:
- Explain the concept of clinical research
- Describe the process of medical product development in the United States
- Differentiate the types of clinical research studies
- Examine historic events that led to standardization of clinical research conduct
- Describe the core ethical principles, regulations, and guidelines that ensure human subjects rights and protections
- Explain the significance of the informed consent process
Course 2: Clinical Study Management I
October 28 – December 22, 2024
In this course, trainees will be provided with the concepts and tools required to begin a clinical research study. Topics will include research protocol development, feasibility evaluation, study budget development and management, IRB and regulatory submissions, study recruitment planning, clinical study initiation visit, and maintenance of essential documents. Trainees will engage in practical applications, including a protocol-specific worksheet activity, budget development, and the recruitment plan for the assigned protocol.
By the end of Course 2, trainees will know how to:
- Outline the steps involved in the study initiation process
- Evaluate a clinical research protocol
- Develop an informed consent document
- Apply the principles of study budget development
- Identify essential documents for clinical research
- Develop the steps for developing a clinical research database.
Course 3: Clinical Study Management II
January 6–March 2, 2025
In the final course, trainees will explore concepts related to the management and coordination of the initiated clinical research study. Topics will include recruitment and screening of research participants, obtaining informed consent for research, study coordination, research compliance, investigational product, reporting adverse events, data collection and management, and study oversight. Real-world application activities will include evaluation of simulated informed consent and study visits, mock eligibility screening, and adverse event evaluation.
By the end of Course 3, trainees will be able to:
- Discuss the elements of clinical research coordination
- Evaluate a participant for study eligibility
- Analyze unanticipated problems and adverse events
- Transcribe source data into electronic case report form
- Describe and differentiate the types of study oversight and how to prepare for each
- Conduct a simulated informed consent process visit
The curriculum is consistent with the content areas of the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA) basic certification exams. Trainees with one year of clinical research experience will be eligible to sit for the SoCRA certification exam, and those with two years of clinical research experience will be eligible to sit for the basic ACRP certification exam.
