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Milestones in Development of Good Clinical Practice

Publisher : Internet Journal of Health,

Campus : Kochi

School : School of Pharmacy

Year : 2009

Abstract : Good Clinical Practice (GCP) is a standard for design,conduct, performance, monitoring, auditing, recording,analysis and reporting of clinical trials that providesassurance that the data and reported results are credible andaccurate, and that the rights, integrity and confidentiality oftrial subjects are protected. The present day guidelines onGCP have evolved through a series of regulations and policyformulations. This is increasingly considered as an essentialpart of drug regulation. These guidelines have been evolvedwith consideration of WHO, ICH, USFDA and EuropeanGCP guidelines as well as the Ethical guidelines forBiomedical Research on Human Subjects issued by theIndian Council of Medical Research. They should befollowed for carrying out all biomedical research in India atall stages of drug development, whether prior or subsequentto product registration in India. This article describes themajor milestones in the evolution of Good Clinical Practices.Good clinical practice (GCP) is an international ethicalscientific quality standard for designing, conducting,recording and reporting trials that involve the participationof human subjects. It also ensures that the rights, welfare andsafety of subjects involved in trials are maintained and areconsistent with the principles stated in the World MedicalAssociation Declaration of Helsinki, entitled ‘ethicalprinciples for medical research involving human subjects1.‘Guideline CPMP/ICH/135/95 entitled good clinicalpractice’ was developed under the subject of InternationalConference on the Harmonisation of the technicalrequirements for the registration of human pharmaceuticals(ICH process) and is applicable in the European union of theUnited States and Japan. Clinical trial data that havedeveloped according to the guideline should therefore beacceptable by regulatory authorities in each of the threeregions, together with Australia, Canada, Nordic countriesand the World Health Organisation which was also involvedin its development2.The definition of GCP given in the guideline is ‘a standardfor the design, conduct, performance monitoring, auditing,recording, analysing and reporting of clinical trials thatprovides assurance that the data and reported results arecredible and accurate, and that the rights, integrity andconfidentiality of trial subjects are protected.’The present day guideline on GCP has evolved through aseries of regulation and policy formulations. The majormilestones in the evolution of GCP are as follows.

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