How do Clinical Research Coordinators Gain Knowledge of Good Clinical Practice?

  • Grant

    Washington University CTSA
    UL1TR000448
    9/17/07 – 5/31/18

  • Team

    • James Dubois, DSc, PhD
      Principle Investigator
    • Jessica Mozersky, PhD
      Co-investigator
    • Alison L. Antes, PhD
      Co-investigator
    • Kari Baldwin, MSW
      Research Assistant
    • Michelle Jenkerson
      Collaborator

Description

The purpose of this study is to examine how clinical research coordinators (CRCs) gain knowledge of Good Clinical Practice (GCP) in the conduct of clinical trials and what factors predict uptake of GCP knowledge. GCP is an international ethical and scientific quality standard for the design, conduct, and performance of clinical trials that was developed by the International Conference on Harmonization (ICH). Compliance with ICH GCP is meant to assure scientific integrity in clinical trials and protect the rights and safety of research participants. This is a two-phase study, involving qualitative interviews and a survey. Qualitative interviews with CRCs examine their experiences of current GCP training and how they learn GCP outside of mandatory training. The survey includes a GCP knowledge test that we designed based on the core competencies and domains of knowledge covered in existing online GCP training. The survey aims to identify factors that predict individual knowledge of GCP such as prior training and other experiences gained outside of mandatory training.