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|Title: ||DATA SHARING IS PART OF DATA MANAGEMENT: THE NEED FOR A HOLISTIC AND COHERENT VIEW ON RESEARCH DATA MANAGEMENT|
|Authors: ||Loen, Harry Van|
Herrewege, Yven Van
|Issue Date: ||Apr-2019|
|Publisher: ||British Medical Journal Global Health|
|Citation: ||British Medical Journal Global Health 4(Suppl 3):A46.1-A46|
|Abstract: ||Background Awareness of data management (DM) is often
restricted to ‘the cost of computers’ or ‘the need for a database’.
Recently, ‘data sharing’ can be added to this shortlist.
Indeed, in recent years data sharing became often required or
so strongly promoted that the importance of all other aspects
related to DM or data handling in clinical tended still to be
overlooked. However, the development of data sharing guidelines
and associated privacy regulations (e.g. the EU General
Data Protection Regulation) created a new momentum for
highlighting the importance of qualitative data management.
Methods An overview of DM processes is given, within the
framework and challenges of conducting non-commercial clinical
trials in North-South partnerships.
Results The DM workflow of a clinical trial is presented,
highlighting essential DM tasks, deliverables and milestones.
Pre-study tasks and deliverables are addressed: SOPs, a data
management plan, the implementation of a GCP-compliant
validated data management system and compliance to data
quality, privacy, security and standards (e.g. MedDRA, CDISC).
Subsequent study-specific processes including the collection,
entry, querying and cleaning of the data are discussed. In
addition, DM metrics important to guide quality, productivity
and timelines are reviewed while considering their impact on
post-study activities such as data sharing.
Conclusion Data sharing is only one of many DM tasks, at
the end of the DM workflow. Focusing too much on data
sharing while neglecting other DM aspects might lead to
underestimating the workload, resources, quality assurance and
time needed for data management and by and large for the
trial itself. Integrating data sharing into a holistic vision on
data management is paramount for clinical research|
|Description: ||This article has been published in British Medical Journal Global Health 4(Suppl 3):A46.1-A46 and is available in DOI: 10.1136/bmjgh-2019-EDC.120|
|Appears in Collections:||College of Science|
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