Handbook for Good Clinical Research Practice (GCP)
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 subjects are protected and respected, consistent with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines, and ensures the integrity of clinical research data. The conduct of clinical research is complex and this complexity is compounded by the need to involve a number of different individuals with a variety of expertise, all of who must perform their tasks skillfully and effi ciently.
The responsibility for GCP is shared by all of the parties involved, including sponsors, investigators and site staff, contract research organizations (CROs), ethics committees, regulatory authorities and research subjects.
Download
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 subjects are protected and respected, consistent with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines, and ensures the integrity of clinical research data. The conduct of clinical research is complex and this complexity is compounded by the need to involve a number of different individuals with a variety of expertise, all of who must perform their tasks skillfully and effi ciently.
The responsibility for GCP is shared by all of the parties involved, including sponsors, investigators and site staff, contract research organizations (CROs), ethics committees, regulatory authorities and research subjects.
Download
No comments:
Post a Comment