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Brief
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5.17 Any other information (optional)
Please provide any additional information that you believe is relevant to your proposal. This may include, but is not limited to:
- Additional study protocols or documents
- Supporting data or references
- Further explanations or clarifications on any points mentioned above
References
- New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetics Act, 1940.
- GCP guidelines published by CDSCO, DGHS, Govt. of India.
- Ethical Guidelines for Biomedical Research on Human Subjects published by Indian Council of Medical Research, New Delhi.
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