To perform a clinical investigation in India, securing permission from the CDSCO is non-negotiable. A detailed study protocol has to be developed keeping patient safety in mind. The clinical investigation plan should comply with the ethical principles and applicable...
Good clinical practice (GCP) provides guidelines for designing, conducting, recording, and reporting clinical trials that involve human participants. GCP sets standards that need to be followed by conducting clinical trials. It ensures that the rights, safety, and...
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