GCP
Good Clinical Practice

 

The GCP standard (“Good Clinical Practice”, Good Clinical Practice) is an international standard of ethical standards and quality of scientific research that describes the rules for the development, conduct, documentation and reporting of studies that imply the participation of a person as a test subject (clinical studies). The compliance of the research with this standard indicates public observance of the rights of research participants, the rules to ensure their safety, the desire to not cause harm, as well as the requirements for the reliability of research. These rules were initiated in the Helsinki Declaration of the International Conference on Harmonization (ICH).

In conjunction with the standards of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice), it is called upon to standardize some aspects of the quality of medical care for the population.

 

Good Clinical Practice
Guidance for Industry
Pharmacogenomic Data Submissions
Regulatory requirements for conducting clinical trials of drugs
Clinical Trial Documents
RESPONSIBILITY OF THE SPONSOR. MONITORING AUDIT.
ETHICAL PRINCIPLES OF CLINICAL TESTING. PATIENT INFORMED CONSENT
Clinical Trials Inspection in Ukraine
History of the creation and implementation of GCP rules. Legal and regulatory requirements for conducting clinical trials of drugs in Ukraine.
Regulatory requirements for clinical trials of drugs
The procedure for conducting clinical trials of medicines