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| INTRODUCTION |
SAMEEKSHA IEC is an Independent Ethics Committee, initiated
and constituted by members from various fields to review,
approve, initiate and conduct periodic reviews of clinical and biomedical
research involving human subjects with a primary object of protecting the
rights and ensuring safety & wellbeing of human subjects involved in such
research or investigations.
SAMEEKSHA IEC reviews the clinical investigations that are regulated by :
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Schedule Y (CDSCO) of Drugs and Cosmetics Act 1940 of India
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United States Food and Drug Administration (USFDA) Regulations (21 CFR Part 50
– Protection of Human Subjects, 21 CFR Part 56 – Institutional Review Board)
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Ethical Guidelines for Biomedical Research on Human Subjects, ICMR 2006
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Any other clinical, bio medical investigations / research carried on human
subjects / volunteers / patients under any other regulatory authorities across
the world.
The committee is having its own Constitution and Working Guidelines and for
smooth functioning of the committee,it follows written SOPs.
Any Investigator / CRO can submit protocols and necessary documents for
approval of the protocol for BA/BE studies and clinical trials.
For more details, Contact us |
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