NIH Clinical Center: Introduction to the Practice and Principles of Clinical Research

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Introduction to the Practice and Principles of Clinical Research

formerly the Core Course in Clinical Research

NIH Clinical Center
National Institutes of Health

US Department of Health and Human Services
Public Health Service

The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a study curriculum on how to effectively conduct clinical research. Most medical schools lack a formal course in training for clinical research, and investigators have relied on mentors to learn how to conduct clinical trials.

The IPPCR was established at the NIH Clinical Center, the clinical research hospital of the National Institutes of Health. The program trains researchers in how to design a successful clinical trial by focusing on epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance and FDA issues. Other areas covered include data management and ethical issues, including protection of human subjects.

The course is offered yearly at the Clinical Center. A certificate is awarded upon successful completion of the course, including a final exam. This activity will be of interest to physicians and other health professionals training for a career in clinical research.

Course Objectives:

To become familiar with the basic epidemiologic methods involved in clinical research;
To be able to discuss the principles involved in the ethics of clinical research, the legal issues involved in clinical research, and the regulations involved in human subjects research, including the role of IRBs in clinical research;
To become familiar with the principles and issues involved in monitoring patient-oriented research; and,
To be able to discuss the infrastructure required in performing clinical research and have an understanding of the steps involved in developing and funding research studies.

The National Institutes of Health/Foundation for Advanced Education in the Sciences (NIH/FAES) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.