DSpace
 

KNUSTSpace >
Research Articles >
College of Science >

Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/13060

Title: DATA SHARING IS PART OF DATA MANAGEMENT: THE NEED FOR A HOLISTIC AND COHERENT VIEW ON RESEARCH DATA MANAGEMENT
Authors: Loen, Harry Van
Thiongo, Mary
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
URI: 10.1136/bmjgh-2019-EDC.120
http://hdl.handle.net/123456789/13060
Appears in Collections:College of Science

Files in This Item:

File Description SizeFormat
DATA SHARING IS PART OF DATA MANAGEMENT THE NEED FOR A HOLISTIC AND COHERENT VIEW ON RESEARCH DATA MANAGEMENT.pdf51.69 kBAdobe PDFView/Open

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

 

Valid XHTML 1.0! DSpace Software Copyright © 2002-2010  Duraspace - Feedback