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Guideline for Good Clinical Practice (GCP)
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THAI FDA
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Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
The National Policy on Clinical Studies states that "Thailand is dedicated to supporting and promoting the conduct of clinical studies in compliance with the Good Clinical Practice Standard so as to ultimately advocate Thailand to be a world-class center of excellence in clinical trials." To achieve the goal Thailand brought ICH GCP as a guideline to be implemented by investigators throughout the country. In addition, Thai Food and Drug Administration states in the criteria and guideline for the bioequivalence study of generic drugs that the study must comply to GCP.
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Download
gcp.pdf
gcp.zip
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