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Class Information for Fundamentals of Clinical Research for Research Support Staff


This one-day course is designed for Clinical Research Support Staff working at the NIH Clinical Center. The program will serve as an introduction to the specialty practice of clinical research and provide the foundation on key concepts essential to the competency: Support of Biomedical Research.

Contact Hours


Target Audience

Clinical Center Nursing Department (CCND) Clinical Support Staff with at least 6 months of experience at the Clinical Center.

Course Objectives

1. Describe basic terminology and concepts in relation to clinical research. 2. Describe the process of protocol review and approval. 3. Discuss ethical issues that may arise when caring for a research participant on a clinical research protocol. 4. Discuss the elements of the informed consent document and the role of the PCT/BHT in helping to maintain ongoing informed consent. 5. Differentiate the following roles in relation to the research protocol and research participant: principle investigator, research nurse coordinator, clinical research nurse, data manager, PCT/BHT, etc.


Clinical Research Support Staff with at least 6 months of experience at the NIH Clinical Center.

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