Good Clinical Practice

Good Clinical Practice (GCP) is an International ethical and scientific quality standard for designing, conducting, recording and reporting research/ trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of research/ trial subjects are protected; consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data generated are credible.

Thus, ICH-GCP training is now a pre-requisite for undertaking any clinical research work and the Drugs Controller General of India (DCGI), Government of India is now demanding ICH-GCP training certificate for personal involved in Clinical research including clinical trial Investigators, Ethics Committee members, Clinical Research Coordinators and consequently pharmaceutical companies prefer GCP trained sites.

Ethics Committee members will be benefited with updating their knowledge on Good Clinical Practice (GCP) guidelines related to Clinical Research and the New CDSCO/ DCGI guidelines for Clinical Research in India.

Duration: Once every six months (April and October)

Course location: Columbia Asia Referral Hospital Yeshwanthpur, Bengaluru

Eligibility: Ethics Committee members

Course Fees: ₹ 3,000/- per session

Contact: Narasimha.vikram@columbiaasia.com

 

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