This is a guideline for investigators conducting clinical trials and drugs testing in Singapore, ensuring that they comply with globally acceptable ethical and scientific standards.
Introduction -- 1. Glossary -- 2. The principles of ICH GCP -- 3. Medical Clinical Research Committee (MCRC) and ethics Committee (EC) -- 4. Investigator -- 5. Sponsor -- 6. Clinical trial protocol and protocol amendment(s) -- 7. Investigator's brochure -- 8. Essential documents for the conduct of a clinical trial.
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All Rights Reserved. National Library Board Singapore 2009.