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Current status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases

PURPOSE: The Prof. Ranjit Roy Chaudhury committee report recommended the accreditation of Institutional Ethics Committees (IECs). Rule 122DD of the Drugs and Cosmetics Act (and Rules) mandates that only registered ECs can accord approval for regulatory studies. We evaluated the current status of reg...

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Détails bibliographiques
Publié dans:Perspect Clin Res
Auteurs principaux: Nishandar, Tushar Bhimrao, Birajdar, Amit Ravindra, Gogtay, Nithya J., Thatte, Urmila M.
Format: Artigo
Langue:Inglês
Publié: Wolters Kluwer - Medknow 2019
Sujets:
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC6463500/
https://ncbi.nlm.nih.gov/pubmed/31008075
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4103/picr.PICR_93_18
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