Good Clinical Practice Guidelines

The document discusses the importance of clinical research in discovering new diagnostic methods and developing modern drugs for disease treatment. Good Clinical Practices (GCP) is an ethical and scientific quality standard for designing, conducting, and recording trials involving human subjects. Compliance with GCP provides assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki.

The document highlights India's unique opportunities for conducting clinical trials due to its large patient pool, trained investigators, and premiere medical institutes. A need was felt to develop Indian Guidelines to ensure uniform quality of clinical research throughout the country and generate data for registration of new drugs before use in the Indian population.

The Good Clinical Practice (GCP) guideline has been formulated by an Expert Committee set up by the Central Drugs Standard Control Organisation (CDSCO). The guideline aims to provide a framework for conducting biomedical studies, ensuring that they are scientifically and ethically sound. It covers various aspects, including protocol design, ethics committee review, informed consent, record keeping, data handling, quality assurance, statistics, special concerns, and audit.

The GCP guideline has been endorsed by the Drug Technical Advisory Board (DTAB) for streamlining clinical studies in India. The document concludes with a statement from Dr. S.P. Agarwal, Director General of Health Services and Chairman, DTAB, expressing confidence that the guideline will be useful to research institutions, investigators, institutional ethics committees, and regulators.

The document provides definitions of various terms related to GCP, including Act, Adverse Event (AE), Adverse Drug Reaction (ADR), Audit of a Trial, Blinding/Masking, Case Record Form (CRF), Clinical Trial, Comparator Product, Confidentiality, Co-Investigator, Contract, Documentation, Escape Treatment, Ethics Committee, Final Report, Good Clinical Practice (GCP), Impartial Witness, Informed Consent, Inspection, Institution, Investigator, Investigational Labelling, Investigational Product, Protocol, Protocol Amendment(s), Quality Assurance (QA), Quality Control (QC), Raw Data, Schedule, Source Data, Sponsor, Study Product, Sub-Investigator, Subject Files/Patient Files, Study Subject, Standard Operating Procedures (SOP), and Subject Identification Code.