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

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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.

Important Dates

Registration	September 3, 2024 – June 27, 2025 (12PM US ET)
Course Access	September 3, 2024 – August 1, 2025
Final Exam Deadline	July 24, 2025 (12PM 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 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.
	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, 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.
	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.