Comments provided on: September 5, 2023
Comments provided to: US Food & Drug Administration
The MRCT Center submitted comments in response to the FDA/ICH E6(R3) Guideline for Good Clinical Practice; International Council for Harmonisation; Draft Guideline for Industry (FDA-2023-D-1955-0002). The MRCT Center applauds the overall structural redesign of the E6(R3) GCP guideline and enthusiastically supports the proposed changes. Our comments identified specific areas that we believe, with revision and improvement, will further protect the rights, safety and well-being of all trial participants.