NIH Investigator Training

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Overview

The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. Other areas covered include data management and ethical issues, including protection of human subjects, building a budget, plus many special topics.

Course Objectives

  • To become familiar with the basic statistical 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 institutional review boards (IRBs) in clinical research, and issues involving special populations.
  • To become familiar with the principles and issues involved in monitoring patient-oriented research.
  • 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.
  • To be aware of emerging technologies and tools which impact clinical research involving data collection, storage, and analysis; electronic records; quality control and others.

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