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India-specific Websites related to Clinical Research

The websites mentioned here give information regarding rules and guidelines involved in the conduct of clinical trials in India.

Indian Council of Medical Research

The description for this site should be given here. Giving a brief introduction to this site will help the student to understand what infomration is available here.

http://www.icmr.nic.in/

Schedule Y (Amended Version)

http://cdsco.nic.in/html/Schedule-Y(Amended Version-2005)original.htm

Central Drugs Standard Control Organization

http://cdsco.nic.in/

Good Clinical Practices for Clinical Research in India (Schedule Y)

http://www.cdsco.nic.in/html/GCP1.html

Indian GCP Guidelines

http://www.cdsco.nic.in/html/GCP.htm

Indian BA / BE Guidelines

http://www.cdsco.nic.in/html/BE Guidelines Draft Ver10 March 2016,05.pdf

ICMR Ethical Guidelines on Bio-Medical Research

http://icmr.nic.in/ethics_SOP.pdf

Mashelkar Committee Recommendation

http://www.cdsco.nic.in/html/Final Report mashelkar.pdf

Adverse Event Reporting Form

http://www.cdsco.nic.in/adr3.pdf

CIOMS Forms

http://www.cioms.ch/cioms.pdf

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