Clinical Research Data Management Toolkit – identifying sound strategies for new projects

IT Innovation ChallengesStudent project led by Amélie Julé

Student round 2016/17

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Getting started on performing a clinical trial, especially if it is investigator-led, is (but should not have to be) a daunting task. Most research projects, but especially clinical ones involving human subjects, require writing-up many procedures and plans; which can be hugely time- consuming for the newcomer without a previous version or template to start from. Too much time is unnecessarily spent on “re-inventing the wheel”, diverting the researcher away from more useful scientific thinking. The Centre for Tropical Medicine and Global Health at the University of Oxford seeks to help clinical investigators, through the provision of free online resources that limit the need for duplication of efforts. The primary audience for the offered tools is research staff in low and middle income countries (LMICs), but clinical research students in Oxford can also learn from the problems faced by their counterparts in low-resource settings, and could benefit from pragmatic solutions addressing issues common to all.
In this project, we aim to develop an online tool facilitating the design of a data management (DM) strategy for clinical research. The tool is expected to take the shape of an interactive “decision tree”, allowing the user to input different characteristics of their intended project e.g. design, size, available resources. According to their answers, the user would be provided with, for example, draft templates for DM plans/DM-related SOPs, as well as suggestions for appropriate DM software and additional capacity to seek. The App could also include reminders for data back-ups, and any other functionality to match the needs of the intended audience.

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