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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.
Electronic submission of Clinical Trial Documents (Amendments, Bioequivalence Studies and Responses) (MCC: 9.59, Jun 2015)
Guideline provides detailed in the Electronic submission process of application for clinical trial.
This guideline provides information to applicants wishing to submit data as evidence of efficacy for veterinary biological medicines
Section 21 Authorisation of Sale of Unregistered Medical Devices