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Course 1 - Fundamentals of Clinical Research: This introductory course will provide trainees with a complete overview of the clinical research process and concepts related to clinical research, including the history of clinical research and the historic events that led to standardization of research conduct and human subjects protections. Trainees will be introduced to the drug development process, types of study design, research sites, roles of the research team, and relevant terminology. Additional topics 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. As a practical element, students will observe an informed consent process and attend a virtual institutional review board meeting from a collaborating institution.
- Discuss clinical research concepts
- 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 for protection of rights and well-being of clinical research participants.
- Discuss the significance of the informed consent process
Course 2 - Clinical Study Management I - This course will provide trainees with concepts and tools needed for the startup of a clinical research study. Topics for this course include research protocol development and evaluation, study budget development and management, IRB and regulatory submissions, clinical study initiation visit, and maintenance of essential documents. This course offers multiple practical elements, including observation of a study initiation meeting, a protocol specific worksheet activity, writing an informed consent for research using a protocol and informed consent template, development of a REDCap database, source documentation and the recruitment plan for the assigned protocol.
- Outline the steps involved in the study initiation process
- Evaluate a clinical research protocol
- Develop an informed consent document
- Examine principles of study budget development
- Identify essential documents for clinical research
- Develop a clinical research database.
Course 3 - Clinical Study Management II - This course will cover concepts related to the management and coordination of the initiated clinical research study. Topics 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. Practicum elements for this course include simulated informed consent and study visits, mock eligibility screening, and observation of a virtual informed consent visit and study visits.
- Discuss the elements of clinical research coordination
- Develop a regulatory binder and identify types of source documents
- Evaluate a participant for study eligibility
- Analyze unanticipated problems involving risks to subjects or others
- 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.
