in Tag: Clinical Trial  (clear all)


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Ethics in Health Research: Principle, Process and Structure

National guidelines on ethics in health research including principles, process and structure for requirements for the ethical conduct of clinical trials.

Related Tags (New Search): GCP,   Clinical trial

Emergency Procedures for Clinical Trial Tests (MCC: 2.41, Oct 2016)

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.

Related Tags (New Search): GCP,   Clinical trial

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.

Related Tags (New Search): Application,   Clinical trial

Efficacy of Veterinary Biologicals (V 1, MCC: 3.06, Jan 2004)

This guideline provides information to applicants wishing to submit data as evidence of efficacy for veterinary biological medicines

Related Tags (New Search): Biological medicines,   Veterinary medicine,   Efficacy,   Clinical trial

Section 21 Authorisation of Sale of Unregistered Medical Devices (V1, MCC: 9.105, Sep 2017)

Section 21 Authorisation of Sale of Unregistered Medical Devices

Related Tags (New Search): Medical devices,   Clinical trial