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

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IPPCR Over The Years

The Introduction to the Principles and Practice of Clinical Research (IPPCR) Course was first launched in September 1995 as a series of lectures delivered live to 25 participants at the NIH Clinical Center in Bethesda, MD. The founder, Dr. John I. Gallin, and a group of experts from within and outside of the NIH, established the curriculum with a focus on issues that were fundamental to researchers: selecting a research question, ethical principles in clinical research, strategies for effective data analysis, and more. The course is now offered in a fully online, asynchronous format, providing participants with flexibility while ensuring the highest quality. Annual enrollment has grown tremendously with every course year, with over 16,000 participants representing more than 150 countries. Thank you to all our faculty, students, and many others around the world who continue to partner with us and make this premier course a success!

Welcome

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The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains participants 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. 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 Objectives

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Syllabus

• 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.

General Information

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• This online course is offered annually at no cost. After registering, participants may begin their study immediately.

• There are approximately 40 pre-recorded lectures (15-90 minutes each), lecture materials, templates, and discussion boards to engage with other participants and the faculty.

• There is an online final exam, which consists of 50-80 multiple choice questions. Participants are permitted to use course materials during the final exam.

• A Certificate of Completion is awarded to each registered participant who achieves a score of 80% or higher on the final exam.

• There is no academic credit or continuing medical education (CME) credit offered for this course.

• Only registered participants are allowed to take the final exam and receive a certificate of completion. However, if you do not wish to enroll in the course, you can still view the individual course lectures through the NIH IPPCR YouTube Playlist or the NIH VideoCast website. Please refer to the course syllabus for the order of lectures.

Important Dates

Registration	9/2/2025 – 6/26/2026 (12PM US ET)
Course Access	9/2/2025 – 7/31/2026
Final Exam Deadline	7/23/2026 (12 PM US ET)

Supplemental Materials

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The course textbook, Principles and Practice of Clinical Research, Fourth Edition (2018, ISBN: 978 0-12-849905-4) is available for purchase from several online book retailers and at the NIH Building 10 FAES book store.

Copies of the textbook can be purchased through Elsevier with a 30% discount and free shipping using the discount code BIOMED30.

Course Directors

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	Lisa Cordes, Pharm.D., BCACP, BCOP – Course Co-Director Dr. Lisa M. Cordes is an Oncology Clinical Pharmacy Specialist and Educator at the National Institutes of Health. She is responsible for designing and teaching educational initiatives, as well as co-directing global pharmacology and research courses. In collaboration with the National Cancer Institute, Dr. Cordes provides clinical expertise, serves as a clinical trials investigator, and offers guidance throughout the drug development process.
	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.
	Anne Zajicek, MD, Pharm.D., FAAP – Course Co-Director (retired) Dr. Zajicek is a board certified pediatrician and pediatric clinical pharmacologist who served as Program Director of the Office of Clinical Research Education and Collaboration Outreach at the National Institutes of Health.

Founder

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John I. Gallin, MD 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.