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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. |
