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PRINCIPLES OF CLINICAL RESEARCH

  1. Lessons learned from experience and from the guidance of others

  2. ICH-GCP PRINCIPLES For Good Clinical Research

     

Lessons learned from experience and from the guidance of others

 

ICH-GCP PRINCIPLES

For Good Clinical Research

 

1. While conducting clinical trials, the ethical principles that have their origin in the Declaration of Helsinki are to be taken into account and the trials are conducted in line with Good Clinical Practice guidelines.

 

2. The risks and benefits associated with the trials must be evaluated before conducting the clinical trials and the trials should only be initiated in case of justification of risks by the associated benefits.

 

3. The rights and safety of clinical trial subjects are to be of first concern and priority than the interest of science.

 

4. There should be a considerable amount of clinical and non clinical information available before starting a clinical trial.

 

5. There should be a well defined and scientifically sound protocol for clinical trial.

 

6. A trial should be in compliance with the protocol that has been approved by International Review Board (IRB) / Independent Ethics Committee (IEC).

 

7. The medical care/advice given to the subjects comes under the responsibility of a qualified physician/dentist.

 

8. Each individual who is participating in the clinical trial must be well qualified for the respective task.

 

9. The consent must be genuinely informed and the informed consent forms must be obtained from every subject.

 

10. The clinical trial information must be accurately maintained to ensure accurate interpretation and verification.

 

11. In accordance with the regulatory rules and respect, the privacy and confidentiality of the subjects that can identify the subject must be strictly maintained.

 

12. The manufacturing and handling of the investigational products should be in accordance to the Good Manufacturing Practices (GMP).

 

13. Only the systems and procedures which ensure the quality of clinical trial in every aspect must be implemented.  

 

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