New NIH Policy on Good Clinical Practice Takes Effect January 1

Good Clinical Practice (GCP) is a process that incorporates established ethical and scientific quality standards for the design, conduct, and reporting of clinical research involving human subjects. It is a crucial component of clinical research, protecting the safety and well-being of study participants. Recently, the NIH issued a new policy stating that NIH-funded investigators and staff should be trained in Good Clinical Practice (GCP). This policy takes effect January 1, 2017. The National Center for Advancing Translational Science (NCATS) led a nation-wide initiative to promote GCP training for clinical trial study team members. A description of the outcomes of that project can be found here. They include:

  • Development of a set of core competencies in 8 domains for education and training for investigators and clinical research coordinators conducting clinical trials
  • A catalog of education and training programs offered across the nation-wide CTSA consortium
  • Three publications to be published in the Journal of Clinical and Translational Science Fall/Winter 2016
  • Creation of a new eLearning course with 9 modules related to the application of the principles of GCP specifically for social and behavioral research