Characterise your study and identify what regulations apply
All regulations follow the principles of ICH-GCP but the way in which they are interpreted and the level of governance will depend on the nature of your study and your local regulations. You need to think about what the intervention is, who your study population is and how the intervention will be implemented – this will help you work out where your study fits in your regulatory environment. For instance there may be different regulations applied to your study depending on if it involves investigational products, taking tissue samples, gene therapy, taking patient data without consent ,involves children as participants and what country the sites are in.
You should be clear what regulations will apply to your study as this will have implications for protocol planning.
4. The Trial Protocol tool has a useful section under RCT Management: http://www.globalhealthtrials.org/site_media/media/articles/trialprotocoltool/TrialProtocolTool.html
5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for Good Clinical Practice E6(R1). 1996; Available from: http://www.ich.org/LOB/media/MEDIA482.pdf.
6. WHO definition of a clinical trial based on requirement for registration; http://www.who.int/ictrp/en/
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