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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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Detalles Bibliográficos
Autores principales: Nishandar, Tushar Bhimrao, Birajdar, Amit Ravindra, Gogtay, Nithya J., Thatte, Urmila M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463500/
https://www.ncbi.nlm.nih.gov/pubmed/31008075
http://dx.doi.org/10.4103/picr.PICR_93_18