1. Good Clinical Practice
Juntra Karbwang MD, DTM&H, PhD
WHO/TDR, Geneva, Switzerland

2. A need for Biomedical Research
The role of disease endemic countries
in biomedical research is increasingly important to the solution of urgent health problems, to the fight against disease and to improvement of global health in general

3. Extending respect for human rights
WHO/TDR POLICY
Clinical trial must be planned and
conducted to reliable standards GCP
Extending respect for human rights
without prejudice to local variations
in attitudes and beliefs

4. Concept of GCP Designing Conducting Recording Reporting
Good Clinical Practice (GCP) is an international ethical and scientific quality standard
Designing
Conducting
Recording
Reporting
Trials that involve participation of human subjects

5. Clinical Trial Conduct in accordance with: Ethical Principles
Declaration of Helsinki
Good Clinical Principles
Regulatory requirements

6. Before initiation of aTrial
Inconvenience
Risk
Benefit for trial subject & Society

7. Initiate & continue a Trial
Only if anticipated
benefit justify RISK

8. Adequate non-Clinical and
Clinical Information
Support Proposed Clinical Trial

9. GCP Basic Principles Credible clinical trial data
Protection of rights, safety, well-being of trial participants
Credible clinical trial data

10. Protection of Trial Subjects
Scientifically Sound
Present in a clear and detailed protocol
Conduct in compliance with IEC/IRB
approval protocol

11. Protection of Trial Subjects
Medical Care & decision
=> Qualified Physician
Each individual involved
=> Qualified by Education,
Training & Experience

12. Prevail over the interest
Protection of Trial Subjects
The rights, Safety & Well-being
Must always...
Prevail over the interest
of Science & Society

13. Protection of Trial Subjects
Adequately Informed:
Aims
Methods
Anticipated benefit
Potential Hazards

14. Protection of Trial Subjects
Informed Consent
“Freely given”

15. Protection of Trial Subjects
Confidentiality of Record
that could identify Subject
=> Should be Protected
Respecting the privacy

16. Quality of Data Trial Information Recorded Handled Stored
Allows its accurate reporting
interpretation & verification

17. } Quality of Data Product - manufactured GMP - Handled - stored
Use in accordance with Protocol

18. Assure the quality of every aspects of the trial
Quality of Data
Implement systems
Assure the quality of every aspects of the trial

19. Framework Clinical Monitor Ethics Committee Investigator Manager
Clinical Coordinator
DSMB
Clinical Monitor
Ethics Committee
Investigator

20. Ethical Review is required
As a support and a guide to the
conscience of the physician
For the protection of research subjects
For public assurance

21. Operational Guidelines for Ethics Committees That Review Biomedical Research
The aim of these guidelines is to provide guidance
for ethics committees concerning appropriate
operating procedures

22. The Aim of the Operational Guidelines
To foster an improved understanding and implementation of ethical review in all countries in the world.
To establish a vehicle for discussing and sharing understanding around the ethical issues.

23. Credible Data Monitoring Investigators Infra-structure at the site
QA/QC Laboratory support

24. MONITORING VISITS Pre - Trial Monitoring visit :
Ensure feasibility in the centre and interest of the investigator.
Trial Initiation visit :
Deliver study material, documents, products and make sure
the investigational team understands the protocol and GCP requirements.
Monitoring visit :
Make sure the study is conducted according to the protocol
and GCP and help the investigational team in solving problems.
Close-out visit :
Make sure the investigator file is archived properly and collect back all unused material, documents or products.

25. Laboratory Quality Assurance
Normal Lab Values
QA/QC
SOPs