Some of the challenges in the implementation of GCP guidelines: 1. Professional Training on GCP 2. Infrastructure 3. Regulatory Environment 4. ERB/ IRB/ IEC 5. ICD Administration 6. Safety Reporting 7. Investigational Product 8. Record Keeping/ Source Document(s) 9. Grants & Payments 10. Trial Report / Publication. The scarcity of GCP trained competent professionals. Lack of professional training on GCP across various stakeholders (sponsor, investigator, ERB, patient, regulators etc). No Indian university offers a curriculum in this Discipline. Most of the hospitals in India do not meet the infrastructure requirements as per GCP guidelines. Lack of supportive infrastructure like labs and diagnostics up to the standards of international accreditation.

Challenges in the implementation of guidelines

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