Clinical trial data will be captured at the investigational sites, transcribed into (electronic) Case Report Forms, and handled respectively cleaned by Data management. This process will result in a database that will be locked (i.e., prevented from unauthorized change or revision), prepared for the proper statistical analysis, and transmitted to the statistician. The development of adequate plans (i.e., Data Management Plan, Data Validation Plan, Statistical Analysis Plan) should be presumed to be an accepted part of the essential documents.
As the security of the robustness of data and their integrity is one of the two major policies in clinical research, the following aspects are to be considered.
Key Considerations for Sponsors:
Early involvement of statistician and data manager.
It seems logical and even a clear necessity that the statistician is involved early in the process of study development. The definition of the study aims, sample size calculation, randomization, and the decision on potential interim analyses will not be possible without a qualified statistician. Operational aspects of the clinical trial will be taken care of by data managers at an early stage. The development of data capture tools for investigators and study subjects (keyword “ePRO”, electronic patient-reported outcome), and the establishment of digital interfaces in case of data collection at vendor companies will be of central importance.
Digital prerequisites and data security.
Software used for electronic data capture, data management, and statistical analyses should be modern, guideline-compliant, and thereby accurate, traceable, and of course reproducible. Endorsement by competent authorities particularly the statistical software would be important concerning the authorization of a medicinal product. For clinical studies in Europe, all processes need to comply with the GDPR (General Data Protection Regulation).
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Autor: Dr. Christoph Ortland, January 2024
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