Prior to initiating a study/clinical trial, researchers must obtain approval from national regulatory authorities (NRAs) and ethics committees to conduct clinical trials. The ethics committees review the integrity of the protocol, because poorly designed studies that are either not needed or cannot answer the question are unethical.
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Ethics & Regulatory
When starting your research, researchers should familiarise themselves with the national framework in place for conducting studies/trials. The researcher must ensure that their piece of research complies with the appropriate national and international standards and guidance, regulations and legislation.
There are various committees, which can be involved in your research. The templates here are associated with those of an Ethics Committee. An Ethics Committee is the authorised body to review documents for research taking place in the insitution.
Through this facility research sites can register and let would-be collaborators and sponsors know about them, their previous experience and what type of research they would like to take part in. In turn, research groups wishing to find other sites to collaborate with can post their research plans and explain what they are looking for in terms of disease prevalence perhaps, or was facilities a research site has.
These free, certificated and recognised courses are provided to give a general introduction to many of the key steps involved in setting up a study they include short topics such as Good Clinical Practice, Good Laboratory Practice and longer modular courses and cover many of the required steps such as setting the question, data management and community engagement.
The Process Map is a cross-cutting tool that guides the process of setting up a study and provides links to explanations about each component step and any tools, templates and training that exist on each step.