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Guideline on Preclinical Safety Studies for Veterinary Medicines. Secular 3.05
National guidelines on ethics in health research including principles, process and structure for requirements for the ethical conduct of clinical trials.
This document outlines the requirements for emergency standard operating procedures which need to be in place during the conduct of clinical trial. It includes the minimum requirements for emergency procedures.
This guideline is intended to assist sponsors of clinical investigations developing strategies for planning and monitoring clinical trial. The guideline includes detail on methodology, risk-based monitoring and strategies to ensure study quality.
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