CTN Webinar: Good Clinical Practice (GCP) Refresher and GCP/GCDMP Trends in the CTN.

Presented by Denise King, MS (CTN Clinical Coordinating Center) and Lauren Yesko (CTN Data & Statistics Center).

Produced by the National Drug Abuse Treatment Clinical Trials Network's Clinical Coordinating Center, March 18, 2015

Good Clinical Practice guidelines provide ethical and scientific standards for the design, quality assurance, data collection, analyses, and reporting for clinical trials. GCP standards ensure that research staff protect the rights, safety, well-being, and confidentiality of trial participants as well as comply with best practices in their conduct of clinical investigations.

This 90-minute presentation focused on the critical aspects of ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials. Presenters Denise King, MS and Lauren Yesko, both of The Emmes Corporation, also discussed Good Clinical Practice (GCP) and Good Clinical Data Management Practice (GCDMP) trends in the National Drug Abuse Treatment Clinical Trials Network (CTN).

Learning objectives included:

  • Review principles and regulatory requirements for GCP.
  • Discuss staff roles and responsibilities, protocol compliance, and other criteria for conducting quality trials.
  • Examine best practices, examples of GCP non-compliance, and corrective actions for protocol or procedural deviations.
  • Identify significant GCP/GCDMP trends in the CTN, such as informed consent, safety, documentation, drug management, and data management.

This webinar is targeted to all interested research staff. (Webinar, Video, PDF, English, 2015)

Keywords: Data collection | Ethics | Quality Assurance (QA) | Training | Clinical Coordinating Center webinar

Document No: 1135

Submitted by Tracee Williams, EMMES, 3/19/2015.

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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 3/2015 --