Data Management in Clinical Research

Abstract

No matter the complexity of a clinical research, one critical component that serves as bridge between conceptualization of research idea and the eventual publication of findings is data management. It encapsulates the whole processes involved in managing the life cycle of data in a clinical research project. Data management can make or mar any research. For example, a research with scientifically sound design but poor, incoherent data management procedure would end up with poor quality data. In this article, the author provides a brief overview of key considerations for data management in clinical research

Click to view file (PDF)

References

CDASH (2011): [Internet] Texas: Clinical Data Interchange Standards Consortium. c2011. [Updated 2011 Jan; Cited 2011 Mar 1]. Available from: http://www.cdisc.org/cdash.

Coursera. Data management for clinical research Vanderbilt University; https://www.coursera.org/course/datamanagement.

Cummings J, Masten J (1994): Customized dual data entry for computerized data analysis. QualAssur. 1994;3:300–303.

Daniel W.W. (2006). Biostatistics: A Foundation for Analysis in the Health Sciences, 7th Edition. Wiley, New Delhi, India.

Data [Internet] Oxford, UK: Oxford University Press; 2014.http://www.oxforddictionaries.com/us/definition/american_english/data

Fegan GW, Lang TA (2008): Could an open-source clinical trial data-management system be what we have all been looking for? PLoS Med. 5:e6.

Gerritsen MG, Sartorius OE, vdVeen FM, Meester GT (1993): Data management in multi-center clinical trials and the role of a nation-wide computer network. A 5 year evaluation. Proc. Annu. Symp. Comput. Appl. Med. Care. 659–62.

Haux R, Knaup P, Leiner F (2007): On educating about medical data management - the other side of the electronic health record.Methods Inf Med. 2007;46:74–79.

Kirkwood R.K. and Sterne J.A.C (2004). Essential Medical Statistics, 2nd Edition. Blackwell Publishing, Oxford, UK

Kuchinke W, Ohmann C, Yang Q, Salas N, Lauritsen J, Gueyffier F, et al (2010): Heterogeneity prevails: The state of clinical trial data management in Europe - results of a survey of ECRIN centres. Trials.2010;11:79.

Lu Z, Su J. (2010): Clinical data management: Current status, challenges, and future directions from industry perspectives. Open Access J Clin Trials. 2010;2:93–105.

National Human Genome Research Institute. All about the Human Genome Project [Internet] Bethesda, MD: The Institute; http://www.genome.gov/10001772.

Ottevanger PB, Therasse P, van de Velde C, Bernier J, van Krieken H, Grol R, et al. (2003): Quality assurance in clinical trials. Crit Rev OncolHematol.2003;47:213–235.

Peat J. and Barton B. (2005). Medical Statistics: A guide to data analysis and critical appraisal. Blackwell Publishing, Oxford, UK.

Read KB, Surkis A, Larson C, McCrillis A, Graff A, Nicholson J, Xu J (2015): Starting the data conversation: informing data services at an academic health sciences library. J Med Lib Assoc. Jul;103(3):131–135.

Study Data Tabulation Model (2007): Texas: Clinical Data Interchange Standards Consortium. c2011. [Updated 2007 Jul; Cited 2011 Mar 1]. Available from: http://www.cdisc.org/sdtm

University of Edinburgh Information Services. Research data management programme: research data management home [Internet]. Edinburgh, UK: The University; http://www.ed.ac.uk/schools-departments/information-services/research-support/data-management/data-management-home.

University of Edinburgh. MANTRA: research data management training [Internet] Edinburgh, UK: The University; http://datalib.edina.ac.uk/mantra/.

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Copyright (c) 2020 Array