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From page 83...
... INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINE FOR GOOD CLINICAL PRACTICE The ICH-GCP was developed as a handbook for researchers conducting clinical trials, particularly drug trials conducted by sponsors and researchers from more than one country (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996, 1997~. Although the guidelines presented in the ICH-GCP are not actually standards, they provide a clear and explicit set of best practices for those conducting clinical trials (see Box 3-1~.


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