GCP is 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. The key stake holders of ICH GCP include IRB/IEC, sponsor, investigator, investigator’s brochure etc. Some essential documents for conducting clinical trial which includes investigator’s brochure, financial aspects of trial, master randomization list etc. The most important consideration of GCP includes right, safety & well being of the trail subject should be maintained. This represents a serious challenge to the academic independent drug related research, as systems to assure GCP compliance must be developed, which in turn requires allocation of appropriate resources.GCP is regulated by drug controller general of India (DCGI). Guidelines of GCP include ICH GCP and INDIAN GCP. The prime difference between INDIAN GCP and ICH GCP include investigator’s qualification and responsibility for data analysis, power of IEC etc.
Loading....