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Data Manager

  • Anna Maria Emili
Chapter

Abstract

This chapter aims at analysing the legal figure of the data manager, in some case defined as a Clinical Research Coordinator and, therefore, at outlining such a status under European Union (EU) rules. International and European Legal sources confer relevance to the data manager, generally, as a recognition for being part of the clinical research community. This definition has indeed a raison d’être, exclusively in relation to the position held by the professional within the experimental clinical research sector.

References

  1. Good Clinical Practice. (n.d.). Retrieved from: http://ichgcp.net/it/
  2. Grimm, N. L., & Tainter, D. M. (2017). Role of the clinical research coordinator in orthopaedic research: Making research less onerous. The Duke Orthopaedic Journal, 7(1), 1–2.  https://doi.org/10.5005/jp-journals-10017-1073 CrossRefGoogle Scholar
  3. Home Associazione Italiana di Oncologia Medica. (n.d.). Retrieved from: www.aiom.it/C_Common/Download.asp?file=/$Site$/files/doc/documenti.
  4. Home NVvOD. (n.d.). Retrieved from: https://www.nvvod.nl/v
  5. Kim, S. S. (2016). Mutual authentication scheme between biosensor device and data manager in healthcare environment. The Journal of Supercomputing, 72(1), 177–184.CrossRefGoogle Scholar
  6. Perfetti, E. (2004/2005). La sperimentazione clinica in oncologia: ruolo e contributo del data manager al miglioramento dei trials clinici in ambito oncologico. Master’s thesis, University of Pavia. Retrieved from: http://www.thinktag.it/system/files/6815/data_manage.pdf?1292164652
  7. Rico-Villademoros, F., Hernando, T., Sanz, J., López-Alonso, A., Salamanca, O., Camps, C., et al. (2004). The role of the clinical research coordinator – data manager – in oncology clinical trials. BMC Medical Research Methodology, 4(1).Google Scholar
  8. Rota, S., & Perfetti, E. (2001). Il data manager in Italia: figura professionale o utopia della ricerca?, A.I.O.M. anno I n°1. [online]. Available at: http://www.medinews.it/bin/Aiom1.pdf
  9. Schnapper, G., Marotti, L., Casella, D., Mano, M. P., Mansel, R. E., & Ponti, A. (2018). Data managers: A survey of the European Society of Breast Cancer Specialists in certified multi-disciplinary breast centers. The Breast Journal.  https://doi.org/10.1111/tbj.13043
  10. Vantongelen, K., Rotmensz, N., & Schueren, E. V. (1989). Quality control of validity of data collected in clinical trials. European Journal of Cancer and Clinical Oncology, 25(8), 1241–1247.CrossRefGoogle Scholar
  11. WMA - The World Medical Association-WMA Declaration of Helsinki. (n.d.). Ethical principles for medical research involving human subjects. Retrieved from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Anna Maria Emili
    • 1
  1. 1.Rights and Science Jean Monnet Centre of Excellence, Department of MedicineUniversity of PerugiaPerugiaItaly

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