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July-September 2021 | Vol 12 | Issue 3
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| Editorial |
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| Addressing challenges faced by trial sites and investigators |
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| Sandeep B Bavdekar |
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| Clinical research, including clinical trials, done appropriately, helps advance science and improves treatments. It is also important that during such research, the safety, well-being, and confidentia... |
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| Review Article |
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| National guidelines for gene therapy product (2019): A road-map to gene therapy products development and clinical trials |
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| Kiruthika Sivagourounadin, Mirunalini Ravichandran, Priyadharsini Rajendran |
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| The “National Guidelines for Gene Therapy Product (GTP) Development and Clinical Trials” prepared by the Indian Council of Medical Research and Department of Biotechnology in 2019 came as ... |
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| Review Article |
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| Conducting community-based pediatric research in rural India: Experience from vadu rural health program |
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| Aditi Apte, Girish Dayma, Himangi Lubree, Anand Kawade, Sanjay Juvekar, Ashish Bavdekar |
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| This paper describes unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India. Some of the ethical issues faced... |
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| Original Article |
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| Compliance of Mumbai-based clinical trial sites with the Quality Council of India guidelines and evaluation of the challenges faced by the investigators |
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| Brinal Figer, Nithya Jaideep Gogtay, Urmila Mukund Thatte |
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| Purpose: A committee chaired by Dr. Ranjit Roy Chaudhary suggested accreditation of investigators, sites and ethics committees to improve the quality of trial conduct in the country. Prior to a... |
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