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Brief
Based on the provided text, I will attempt to provide a response in the format you requested.
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.
Please let me know if this meets your requirements or if you need further assistance!
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