Abstract
Clinical Study Data Management Systems (CSDMSs) support the process of managing data gathered during clinical research. Clinical research involves much more than clinical data management – for example, research-grant tracking and reporting to the sponsor and to institutional review boards (IRBs, also called Human Investigations Committees) as well as financial management. I’ll focus on the data-capture, reporting and query aspects, as these are the components that benefit from metadata.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Abadie R. The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. Durham: Duke University Press; 2010.
Raloff L. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385-401.
Wikipedia. Computerized adaptive testing. 2010 [cited 4/10/10]; Available from: en.wikipedia.org/wiki/Computerized_adaptive_testing.
Cella D, Riley W, Stone A, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63(11):1179-1194.
Thwin SS, Clough-Gorr KM, McCarty MC, et al. Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study. BMC Med Res Methodol. 2007;7:23.
Van den Broeck J, Mackay M, Mpontshane N, Kany Kany LA, Chhagan M, Bennish M. Maintaining data integrity in a rural clinical trial. Clin Trials. 2007;4(5):572-582.
Wisniewski SR, Leon AC, Otto MW, Trivedi MH. Prevention of missing data in clinical research studies. Biol Psychiatry. 2006;59(11):997-1000.
Day S, Fayers P, Harvey DR. Double data entry: what value, what price? Control Clin Trials. 1998;19(1):15-24.
Joint Commission on Accreditation of Hospital Organizations. National Patient Safety Goals. 2008 [cited 11/03/10]; Available from: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/08_hap_npsgs.htm.
Frank E, Cassano GB, Rucci P, et al. Addressing the challenges of a cross-national investigation: lessons from the Pittsburgh-Pisa study of treatment-relevant phenotypes of unipolar depression. Clin Trials. 2008;5(3):253-261.
Dupont W, Plummer W. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998;19:589-601.
Richesson RL, Malloy JF, Paulus K, Cuthbertson D, Krischer JP. An automated standardized system for managing adverse events in clinical research networks. Drug Saf. 2008;31(10):807-822.
Wang X, Hripcsak G, Markatou M, Friedman C. Active computerized pharmacovigilance using natural language processing, statistics, and electronic health records: a feasibility study. J Am Med Inform Assoc. 2009;16(3):328-337.
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2011 Springer-Verlag London Limited
About this chapter
Cite this chapter
Nadkarni, P.M. (2011). Clinical Study Data Management Systems. In: Metadata-driven Software Systems in Biomedicine. Health Informatics. Springer, London. https://doi.org/10.1007/978-0-85729-510-1_14
Download citation
DOI: https://doi.org/10.1007/978-0-85729-510-1_14
Published:
Publisher Name: Springer, London
Print ISBN: 978-0-85729-509-5
Online ISBN: 978-0-85729-510-1
eBook Packages: MedicineMedicine (R0)