M. Pharmacy Quiz-51

The primary purpose of ICH-GCP guidelines is to:

Ensure rapid marketing approval of new drugs

Ensure ethical conduct and scientific quality in clinical trials

Reduce the cost of drug development

Promote pharmaceutical exports

According to Schedule Y (India), an Ethics Committee must include:

Only doctors

Only government officials

A multidisciplinary team including medical, legal, social, and lay persons

Only researchers

Which of the following is NOT a major element of the Informed Consent Document?

Study purpose

Compensation for participation

Name of PI and contact details

Personal beliefs of the investigator

Good Clinical Practice (GCP) guidelines were developed for harmonization by:

CDSCO

US-FDA

WHO

ICH

Which committee reviews the ethical aspects of biomedical and clinical research in an institution?

Data Safety Monitoring Board

Institutional Review Board / Institutional Ethics Committee

Scientific Advisory Board

Regulatory Affairs Team

M. Pharmacy Quiz-51

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