Abstract
To achieve a reliable data set for analysis that complies with the protocol, a system of clinical data management (CDM) is critical. CDM is the planning and process of data collection, integration and validation. This chapter provides a synopsis of the key components of CDM which need to be considered during the design phase of any trial. Topics addressed include the roles and responsibilities of research staff, the design of case report forms for collecting data; the design and development of a clinical database management system, subject enrolment and data entry, data validation, medical coding, database close-out, data lock and archiving. An additional section discusses the rationale behind trial registration.
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References
Chalmers I, Glasziou P, Godlee F (2013) All trials must be registered and the results published. BMJ 346:1–2
De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB, International Committee of Medical Journal, Editors (2005) Is this clinical trial fully registered? a statement from the international committee of medical journal editors. Lancet 365:1827–1829
International Committee of Medical Journal Editors (2015) ICMJE clinical trials registration [Online]. Available: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
International Conference on Harmonisation (2015) ICH official web site : ICH [Online]. Available: http://www.ich.org/home.html
Krishnankutty B, Bellary S, Kumar NB, Moodahadu LS (2012) Data management in clinical research: an overview. Indian J Pharmacol 44:168–172
Liu MB, Davis K, Liu MB, Duke Clinical Research Institute (2010) A clinical trials manual from the duke clinical research institute : lessons from a horse named Jim. Wiley-Blackwell, Chichester/UK/Hoboken
Mcfadden E (2007) Management of data in clinical trials. Wiley-Interscience, Hoboken
Mcgauran N, Wieseler B, Kreis J, Schuler YB, Kolsch H, Kaiser T (2010) Reporting bias in medical research – a narrative review. Trials 11:37
Ohmann C, Kuchinke W, Canham S, Lauritsen J, Salas N, Schade-Brittinger C, Wittenberg M, Mcpherson G, Mccourt J, Gueyffier F, Lorimer A, Torres F, CTR EWGD (2011) Standard requirements for GCP-compliant data management in multinational clinical trials. Trials 12:85
Schulz KF, Altman DG, Mohe D, Group, C (2010) Consort 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 340:c332
World Health Organization (2014) The WHO registry network [Online]. Available: http://www.who.int/ictrp/network/en/
World Medical Association (2008) Ethical principles for medical research involving human subjects [Online]. Available: http://www.wma.net/en/30publications/10policies/b3/17c.pdf
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Senior, H. (2015). Data Collection and Quality Control. In: Nikles, J., Mitchell, G. (eds) The Essential Guide to N-of-1 Trials in Health. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-7200-6_8
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DOI: https://doi.org/10.1007/978-94-017-7200-6_8
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-017-7199-3
Online ISBN: 978-94-017-7200-6
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