Study-specific procedures and plans to facilitate the management of the research and can also be used in the event of an audit to justify the approaches taken.
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Investigators in the Harvard Medical Practice Study define an 'adverse event' as "an injury that was caused by medical management (rather than the underlying disease) and that prolonged the hospitalization, produced a disability at the time of discharge, or both.
Serious Adverse Event (SAE) is defined as: An untoward occurrence that results in death; is life-threatening; requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapacity; or consists of a congenital anomaly or birth defect. There are slight differences in definition for IMPs and non IMPs; Clinical Trial Regulations should be referred to for IMPs.
The type of monitoring may differ greatly between studies. A plan will help establish the overall framework for the oversight and monitoring of a study. When formulating a plan the study team should consider the protocol, phase, intervention(s), target population, subject safety and privacy, risks and benefits involved in the study, data integrity and confidentiality, study coordination, and how the team will address each of these elements.
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.