Ethics

It is essential to observe all ethical requirements for the country concerned. All randomized trials require ethics approval. The guidance we give here conforms in general with the functions of Institutional Review Board/Independent Ethics Committees as set out in the ICH GCP Guideline for international use, the NCI Investigators' Handbook (http://ctep.info.nih.gov/handbook/HandBookText), and the COREC system, and is therefore widely applicable.

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