Lecture 14: Good Clinical Practice

Question 1

Principles of Codes of Good Clinical Practice?

Answer 1

• GCP Responsibilities
• Informed Consent
• GCP Documentation
• Roles of the Sponsor/Monitor
• Adverse Event Reporting

Question 2

List a few responsibilities of investigator for GCP

Answer 2

• Adequate qualifications and facilities for the study
• Access to appropriate patient population
• Conduct study as per protocol ( FDA Form 1572), either personally or with
fully informed co-investigators
• Ethics Committee properly constituted and approvals obtained prior to study
commencement. On-going communication with IEC
• Informed consent from participants
• Review Investigators Brochure
• Reporting of adverse events which occur during study
• Maintain & archive accurate records which are available for inspection
• Patient safety

Question 3

List a few responsibilities of sponsor/monitor for GCP

Answer 3

• Study Protocol and Amendments
• Investigator Brochure and Updates
• Notify Serious and Unexpected Adverse Events/other new findings
• Confirm review and approval of Ethics Committee
• Release study drug only when all required documentation is in place
• Maintain drug accountability records
• Follow written monitoring procedures (Standard Operating Procedures)
• Permit regulatory authority inspections
• Final study report
• Archiving

Question 4

What is a SAE?

Answer 4

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