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Good Clinical Practice (GCP) for Social and Behavioral Research Field Guide

Based on NIH's Online Training Module available through CITI, MyLearning and Society of Behavioral Medicine's ELearning course

NIH now requires that all "clinical trial staff", e.g. "individuals responsible for study coordination, data collection, and data management", working on a "clinical trial", e.g. "research studies in which one or more human subjects are prospectively assigned to one or more interventions....", completed GCP training. The training guide below is taken directly from the NIH course, with some adaptation to JHSPH IRB policies on defining "protocol deviations" and reporting requirements. It is intended to be used as an in-person training tool, with an investigator-generated assessment. We have provided a template form, "Certification of GCP Training", for investigator use to document successful completion of GCP training. This documentation should be provided to the IRB and retained in the study files.  

The topics covered in this guide are broad, and provide a good basic background for any study, whether or not it involves a clinical trial.  We hope that it will be used broadly.  

GCP Field Guide

GCP Field Guide, French Translation-Courtesy of the Center for Communications Programs (CCP), translated by Lionbridge

Certification of GCP Training Form