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Internal
CEBU
This is the hospital's Clinical Epidemiology and Biostatistics Unit. Their staff have extensive experience in assisting with a wide range of studies, and provides specific technical expertise in study design (including sample size calculation), preparation of randomisation schedules, data entry and data management, and statistical analysis. CEBU also offers short courses, including "Getting Started in Clinical Research," which provides an essential foundation in the principles and methods needed for sound clinical research. Their website contains contact details for seeking assistance, details of courses and some information on statistical software.
RCH Ethics and Research Office
This office is responsible for managing the ethical review process and various research management functions including legal and regulatory requirements. It is essential to gain an early understanding of the issues you will need to cover in your ethics application. Their website contains full guidelines for ethics applications including the necessary forms, and staff are available to meet with researchers on an individual basis to discuss applications prior to submission.
MCRI Grants Office
This office advises on funding opportunities and coordinates applications for research funding.
Australian Paediatric Pharmacology Research Unit (APPRU)
APPRU was established to conduct clinical trials of pharmaceuticals in children, and has considerable expertise in this area.
External
CONSORT Statement
(Consolidated Standards of Reporting Trials). This provides standard guidelines for reporting randomised trials, and has been adopted by all major medical journals. These detailed guidelines consist of a checklist that authors should use for reporting trials. This checklist is also a useful guide when writing a research proposal.
TGA (Therapeutic Goods Administration).
This is the governing body of regulatory requirements. The requirements need to be addressed when preparing a protocol for a clinical trial of a therapeutic agent.
Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA comments (PDF)
This is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. The TGA has annotated this document for Australia. Section 6 of this document outlines Clinical Trial Protocols and Protocol Amendments - see p. 34-37 (N.B. if viewing within your web browser, select pages to be printed by using the print icon on the Adobe toolbar).
MRC Guidelines for Good Clinical Practice in Clinical Trials 1998 (PDF)
These are detailed guidelines for good practice published by the UK Medical Research council.
Access to Unapproved Therapeutic Goods in Australia - Clinical Trials in Australia (PDF)
This document details information required by the Ethics Committee on the medication (e.g. Investigator's Brochure) and dealing with adverse events. [See especially p68-79]
The Cochrane Library
This is a unique source of reliable and up-to-date information on the effects of interventions in health care. Published on a quarterly basis, The Cochrane Library is designed to provide information and evidence to support decisions taken in health care and to inform those receiving care and consists of a regularly updated collection of evidence-based medicine databases.
NHMRC (National Health and Medical Research Council).
The NHMRC is Australia's expert body providing research funding, consideration of ethical issues and development of advice and regulation of sensitive research activities.