CDSCO Releases Draft Guidelines on Good Clinical Practices

Good Clinical Practice is a set of guidelines for biomedical studies that encompasses the design, conduct, termination, audit, analysis, reporting, and documentation of the studies involving human participants. The fundamental tenet of GCP is that in research on human subjects or participants, the interests of science and society should never take precedence over considerations related to the well-being of the study participant. It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are properly documented.

The guidelines seek to establish two cardinal principles: protection of the rights, safety, and well-being of participants/subjects and authenticity of biomedical/clinical data generated.

After a detailed discussion, the committee prepared draft guidelines on good clinical practices.

The committee opined that the proposed draft guidelines may be circulated to various stakeholders by placing it on the CDSCO website for seeking comments before finalization of the guidelines

Accordingly, the said draft guidelines on Good Clinical Practices are being published on the CDSCO website for comments/suggestions within period of 30 days by email to dci@nic.in.