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 …

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 …

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 …

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 …

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 …

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 …

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 …

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. …