By Gillian Gittens, Director of eClinical Strategy and Solutions
The preliminary edition of the ICH Harmonized Guideline on Good Clinical Practice (GCP) E6(R3) marks a notable progression in the realm of clinical trial administration, particularly concerning the Trial Master File (TMF). This extensive guideline ushers in a range of pivotal enhancements that are primed to have a substantial influence on the manner in which clinical trials are executed and documented.
These guidelines underscore the significance of risk-based strategies and heightened preparedness for inspections by augmenting content requisites, enhancing document management, and refining quality control. Furthermore, the guidelines take significant strides in addressing the growing integration of technology in clinical trials, particularly in terms of electronic records and systems.
Access the full article below to take a deeper dive into each of these improvements.