Introduction to Good Clinical Practice

Learn the globally recognized standard for conducting ethical and scientifically sound research and to “speak” the universal language of clinical research. This eLearning course is an excellent starting point for anyone wanting to begin work in clinical research and a great refresher for those who have been in the role for some time.

FDA Logo

FDA Mailbag: Agency Addresses Compensation Ethics

Clinical trial practitioners seeking direct U.S. Food and Drug Administration (FDA) input for specific questions can leverage an online service from the agency’s Office of Good Clinical Practice. While comprehensive, it is an often-overlooked and cumbersome data repository. In this occasional series, ACRP wades through the posted questions and answers and provides highlights some of […]

Mariette Marsh, MPA, CIP, Director, Human Subjects Protection & Privacy Program, University of Arizona

PIs Struggle with Increasingly Complex Oversight Demands

Lack of adequate oversight and improper delegation of authority continue to dog clinical trial operations. One or both of those problems are frequently cited by U.S. Food and Drug Administration (FDA) investigators in Form FDA 483s (“Inspectional Observations”) after inspection of a study facility, notes Mariette Marsh, MPA, CIP, director of the Human Subjects Protection […]