Good Clinical Practice

1
Good Clinical Practice

• Steve Dean
• Chairman of CVMP

2
Introduction to GCP

• A guideline for international regulation
• A measure of good science
• Key issues for the implementation of GCP

3
A guideline for international regulation

• Developed at VICH as an international standard
  for clinical studies
• Protocol design
• Conduct and monitoring of trials
• Audit and reporting format
• Encompasses the best judgement of regulators
• Provides a base for public assurance
• Reliable clinical data
• Animal welfare
• Clinical personnel and owner safety
• Protection of human health and the environment

4
A measure of good science

• Clearly defined roles
• Qualification of the investigatory team and
  facilities
• Sponsor/monitor/auditor
• Clearly defined procedures
• Protocols and amnedments
• Standard operating procedures
• Clearly defined record keeping requirements
• Informed consent
• Animal records
• Product accountability
• Documentation for Investigator/Monitor
• Study documentation
• Final report

5
Key issues for the implementation of GCP

• Clear, understandable protocols
• Investigators with understanding (science,
  species, disease and product)
• Active monitoring
• Clear product records
• Clear, durable records and documentation
• Training of monitors and investigators