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Introduction to the Principles and Practice of Clinical Research (IPPCR)


The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains registrants on how to effectively and safely conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting biostatistical and epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much more.

Course Objectives

  • Provide an overview of basic biostatistical and epidemiologic methods involved in conducting clinical research.

  • Describe the principles involved in the ethical, legal, and regulatory issues in clinical human subjects research, including the role of Institutional Review Boards (IRBs).

  • Describe principles and issues involved in monitoring patient-oriented research.

  • Describe the infrastructure required in performing clinical research and the steps involved in developing and funding research studies.

Intended Audience

This course will be of interest to physicians, scientists, medical and dental students, nurses, public health professionals, and others conducting or planning a career in clinical research.

Course Directors

Anne Zajicek, M.D., Pharm.D., FAAP Anne Zajicek, MD, Pharm.D., FAAP – Course Co-Director
Dr. Zajicek is a board certified pediatrician and pediatric clinical pharmacologist who currently serves as Program Director of the Office of Clinical Research Education and Collaboration Outreach at the National Institutes of Health.
Lisa Cordes, Pharm.D., BCACP, BCOP – Course Co-Director Lisa Cordes, Pharm.D., BCACP, BCOP – Course Co-Director
Dr. Lisa M. Cordes is an Oncology Clinical Pharmacy Specialist and Educator for the National Institutes of Health. In her current position, she provides clinical and protocol support to the Genitourinary Malignancies Branch and the Clinical Pharmacology Program of the National Cancer Institute, and is co-director of the Principles of Clinical Pharmacology course.
John I. Gallin, M.D. Laura Lee Johnson, Ph.D. – Course Co-Director
Laura Lee Johnson, Ph.D. is the patient focused drug development liaison and the division director for the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, implementation, and analysis of research studies of all sizes and in measurement tool and endpoint development. Prior to working at the FDA she spent over a decade at the U.S. National Institutes of Health working on and overseeing clinical research and research support programs.
John I. Gallin, M.D. John I. Gallin, MD – Course Co-Director (retired)
Dr. John Gallin served as the National Institutes of Health's Associate Director for Clinical Research and Chief Scientific Officer of the NIH Clinical Center from 2017-2023. He has published more than 365 articles in scientific journals and has edited two textbooks – "Inflammation, Basic Principles and Clinical Correlates" (Lippincott, Williams, and Wilkins, 1999, now in 3rd edition) and "Principles and Practice of Clinical Research" (Academic Press, now in 4th edition, 2018). Dr. Gallin is a member of the American Society for Clinical Investigation, the Association of American Physicians, the National Academy of Medicine, and he is a Master of the American College of Physicians.


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