Oct 11, 2024 · The following resources are provided to help investigators, sponsors, and contract research organizations who conduct clinical studies on investigational new drugs comply with …

Jan 21, 2021 · Here are links to FDA regulations governing human subject protection and the conduct of clinical trials. Each time Congress enacts a law affecting products regulated by the …

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human...

Jun 7, 2023 · The draft guidance outlines modernized Good Clinical Practice considerations to guide thoughtful design and responsible conduct of clinical trials in a manner that ensures …

The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. The 12 modules included in the course are based on …

In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving …

On January 6, 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued its final version of the “Guideline for Good …

The draft guidance outlines modernized Good Clinical Practice considerations to guide thoughtful design and responsible conduct of clinical trials in a manner that ensures participant safety...

FDA regulated research is required to conform to standards of Good Clinical Practice (GCP). Section 8 of the GCP guidelines outlines the “Essential Documents” that investigators are …

Nov 13, 2018 · What is Good Clinical Practice (GCP)? • While FDA regulations do not have a stand alone definition of GCP, it is defined in 21 CFR 312.120 (Foreign clinical studies not …