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 ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S.

2021年1月21日 · 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 Food and Drug...

There are two types of clinical studies: interventional studies (also called clinical trials) and observational studies. The unique identification code given to each clinical study upon …

2024年10月11日 · The following resources are provided to help investigators, sponsors, and contract research organizations who conduct clinical studies on investigational new drugs comply with U.S. law and...

GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials. Improve site activation time and reduce training time with mutually-recognized, effective, engaging training.

Guidance documents listed below represent the agency's current thinking on the conduct of clinical trials, good clinical practice and human subject protection. Guidance documents are not...

Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientifi c quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of research

The ICH guideline for good clinical practice (GCP) establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants. It outlines the responsibilities of sponsors, investigators, and other stakeholders to protect the rights, safety, and well-being of trial participants, while ...

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 human subjects.

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are ...