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GCP Supplementary Materials

Congratulations to everyone who participated in the Good Clinical Practice training with Tanya Symons on 25 September 2018. 

Supplementary Notes and Web Links v118 ICH R2



Clinical Trials Registers

World Health Organisation International Clinical Trials Registry Platform (a search portal that imports data from registries worldwide) 

Australian New Zealand Clinical Trials Registry

ClinicalTrials.gov (hosted by the U.S. National Library of Medicine, includes US and international studies)

NHMRC Australian Clinical Trial Registries (includes Australian single-issue registries)

ISRCTN Registry (UK based registry)

European Clinical Trials Register

Clinical Trial Toolkits

Australia: https://www.australianclinicaltrials.gov.au/clinical-trials-toolkit

UK: http://www.ct-toolkit.ac.uk/

Although the information may not be strictly applicable to Australian researchers, the UK Toolkit is extensive, detailed and has a visual map of the legal and good practice steps in beginning, managing and completing a clinical trial.

Other

The Research Ethics Guidebook – a resource for social scientists

A well-written and detailed guide on a user-friendly website, considering each step in the research process. Aimed at non-medical researchers based in the UK. The sitemap page allows you to compile the pages you want into one printable document.

HRA Decision Tools

These tools from the UK’s Health Research Authority are based on the UK Policy Framework for Health and Social Care Research, and created with UK research bodies to assist researchers answer the questions:

‘Is my study research?’

and

‘Do I need ethics approval?’










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