GCP Guidelines for Clinical Trials in ASU (Ayurveda, Siddha, Unani)

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The department of AYUSH has issued good clinical practice (GCP) guidelines for clinical trials in Ayurveda, Siddha and Unani (ASU) medicines which will facilitate the researchers and institutions in adopting a standard way of good clinical practice while conducting the ASU clinicaltrials.

The guidelines are addressed to investigators and all those, who are interested, concerned, involved and affected with the conduct of clinical trials on ASU drugs. These are timely in view of the focus being given for scientific validation and for promoting evidence-based use of ASU treatments and are meant for voluntary use, not linked with any provisions of Drugs & Cosmetics (D&C) Act, 1940, and the rules there under.

Good Clinical Practice is a set of guidelines which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. The fundamental tenet of GCP is that in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject. It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the ASU medicine under investigation are properly documented.

The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of ASU medicine clinical trial data generated. These guidelines are formulated based on CDSCO Document on GCP Guidelines (2001) for Clinical Trials on Pharmaceutical Products. They should be followed for carrying out all ASU medicine research in India at all stages of drug development, whether prior or subsequent to product registration in India.

CONTENTS :

1.      Introduction
2.      Pre-requisites for the study
3.      Responsibilities
4.      Record Keeping and Data Handling
5.      Quality Assurance
6.      Statistics
7.      Special Concerns

 

APPENDICES

Appendix I            : Guidelines for Evaluation of Ayurveda, Siddha and Unani Medicine

Appendix II          : Ethical Issues (Ethical Guidelines for Biomedical Research Human Participants, Indian Council of Medical Research 2006

Appendix III         : Investigator’s Brochure

Appendix IV         : Essential Documents

Download the GCP -ASU from here http://indianmedicine.nic.in/writereaddata/linkimages/5110899178-Final%20Book%2028-03-13.pdf

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One thought on “GCP Guidelines for Clinical Trials in ASU (Ayurveda, Siddha, Unani)

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