e6(r2): good clinical practice (gcp)

What are the Roles and Responsibilities in GCP?

Various stakeholders have specific roles and responsibilities to ensure GCP compliance:
1. Investigators: Responsible for the conduct of the trial at their site, ensuring protocol adherence, and safeguarding participant welfare.
2. Sponsors: Ensure that trials are conducted according to GCP and regulatory requirements. They also provide the necessary resources and oversight.
3. Ethics Committees: Review and approve study protocols, ensuring that ethical standards are met and participants' rights are protected.
4. Regulatory Authorities: Monitor compliance with GCP and other regulations, and have the authority to inspect trial sites and records.

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