10. Roadmap of the Submission Process of a Clinical Trial
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10. Roadmap of the Submission Process of a Clinical Trial
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- DarkLight
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10.1 Clinical Trial with Investigational Medicinal Product
10.2 Pediatric Investigation Plan
A PIP (or equivalent) is not required in India. Trials involving children are reviewed and approved in the same way as other clinical studies.
10.3 Clinical Study (Interventional or Observational)
DCGI approval is only required for interventional studies.
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