GCP (U.S. FDA Focused) (this is the first (old) GCP Course)

This course is a 13-module program that discusses good clinical practice as it relates to clinical trials of both drugs/biologics as well as devices.  The discussion is focused on the U.S. Food and Drug Administration (U.S. FDA) regulatory requirements, but does contain information related to International Conference on Harmonisation (ICH) guidelines, which were adopted to aid in compliance with regulatory requirements of the multiple government agencies.  Modules include Overview of New Drug Development, FDA Regulated Research and ICH for Investigators, Investigator Obligations in FDA-Regulated Clinical Research, and Informed Consent.

 GCP Drugs (ICH-Focused/International)

This course is a 13-module program that provides information on good clinical practice as it relates to clinical trials involving drugs and biologics.   The information is presented in the context of International Conference on Harmonisation (ICH) guidelines, but also includes relevant U.S. FDA regulations and guidance.  Modules include ICH overview; ICH- Comparison between ICH GCP E6 and U.S. FDA Regulations, Audits and Inspections in Clinical Trials, Conducting Investigator-initiated Studies According to FDA Regulation sand Good Clinical Practices, and Informed Consent.  This course may be most appropriate for organizations or individuals who desire a more international focused GCP curriculum.

 GCP Device (International)

This course is a 10-module program that provides information on good clinical practice for clinical trials involving devices.  The information is presented in the context of both ICH guidelines and U.S. FDA regulations and guidance.  Modules include Managing Investigational Devices According to GCP Requirements, Audits and Inspections in Clinical Trials, Conducting Investigator-initiated Studies According to FDA Regulation sand Good Clinical Practices, Monitoring of Clinical Trials by Industry Sponsors, and Informed Consent.  This course may be most appropriate for organizations or individuals who desire a more international focused GCP curriculum or a more device-focused program.

To order any of the GCP courses, please use you the attached order form.