Objective of the Program
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To enhance awareness of ethical, regulatory, and scientific dimensions of clinical research.
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To enable healthcare professionals to comply with ICH-GCP and Indian GCP guidelines.
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To build institutional and investigator capacity for high-quality, ethical clinical trials.
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To instill best practices in documentation, monitoring, and reporting within trial settings.
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To prepare participants for audits, inspections, and regulatory scrutiny.
Outcome of the Program :
Upon successful completion of the program, participants will be able to:
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Demonstrate a solid understanding of Good Clinical Practice (GCP) principles and their application.
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Identify the ethical, legal, and scientific responsibilities of sponsors, investigators, and ethics committees.
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Design and review clinical trial protocols, informed consent forms (ICFs), and essential documents.
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Comply with national (CDSCO, ICMR) and international (ICH E6 R2, WHO) regulations for human research.
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Implement effective quality assurance, safety reporting, and data integrity mechanisms.
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Address GCP violations and develop mitigation strategies during audits and inspections.
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Enhance institutional readiness for regulatory accreditation (e.g., NABH, SIDCER).