We use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials.
All research studies on human subjects should have a level of quality and ethical standard assurance built into their operations to ensure that that the rights and well-being of human subjects are protected and that the data are reliable. This combined template and guide assists research teams in developing a QA plan for their study.
This guide will set out why quality management and monitoring is important and how it can be easily and practically built into a study.
A coherent four step plan for implementing in-house or reciprocal monitoring systems at a research site
There has been a trend over recent years towards the use of expensive contract organisations to monitor research studies and this can be expensive and is not necessary. This overview explains the reasons for reciprocal monitoring, and how it can benefit research groups.
One of the goals of the REDe network is to support the conduct of high quality research by providing tools, training and guidance in all the elements that are required. A very fundamental, but often overlooked, piece in this is the planning and implementation of research quality management (which is often referred to as monitoring).
There has been steady progress in LMIC health research capacity, but major barriers to research persist and more empirical evidence on development strategies is required.
New to monitoring clinical research trials? Ogundokun Olusegun outlines some of the responsibilities and tasks that the role involves, from revieiwing sites and managing research centers to the lifestyle pressures on the road.
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.
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