The body of guidelines and regulations outlining the responsibilities of sponsors, investigators, monitors, and IRB's for clinical trials, to ensure protection of safety, rights, and welfare of patients, subjects, and to ensure integrity and quality of clinical data collected.
Principles and guidelines of good clinical practices to ensure that the performance of clinical trials and testing of pharmaceutical products in man is based on the protection of human rights and human dignity. Regulations concerning manufacturing, uptake, design, processing and reporting of clinical studies for pharmaceutical products which are foreseen for human use.
International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate, and that the subject's rights and confidentiality are protected.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.
An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials.
Good clinical practice is a set of rules and regulations that is provided by International Conference on Harmonisation (ICH) - an international body that regulates clinical trials involving human subjects.