CTSA Program Good Clinical Practice Standards Published

Group of scientists around a tv/computer screenTo improve the translational science process, clinical trial personnel must be qualified and have the necessary skills to implement safe and efficient studies. To help meet this goal, Clinical and Translational Science Awards (CTSA) Program hub investigators collaborated to establish ethical and scientific quality standards and competencies — called good clinical practice (GCP) — for the design, conduct, recording and reporting of clinical research involving human subjects.

GCP is composed of three phases, which the investigators described in three recent papers in the Journal of Clinical and Translational Science. In the first phase, the investigators developed a consensus across the CTSA Program national network about training guidelines and standards in the implementation of clinical trials. The second phase focused on developing competencies and minimum qualifications for a training curriculum for researchers involved in clinical studies. During the third phase, the investigators established best practices for conducting social and behavioral research, with the goal of creating learning modules. Hub personnel are currently testing the effectiveness of the GCP training standards at their respective institutions.

Posted February 2017