Misconception #4 on eCOA barriers: Preparing for eCOA requires additional lead time
Time is of the essence for any clinical study. Nobody wants to lose time when starting a clinical trial.
According to a survey led by the Critical Path Institute’s ePRO Consortium there seems to be a misconception that “timing for set-up is longer when using eCOA solutions”1, but this stems from misunderstandings.
The time needed for translation, back translation, and digitalization of questionnaires is not necessarily longer than that taken simultaneously by CROs to select, set up, and fully initiate sites. With robust project management of the study start up activities and thorough identification of all activities that can be conducted in parallel, eCOA implementation can allow to save weeks!
All data transcription, clarification, reconciliation, and final database cleaning processes are significantly longer when using paper, due to the lower quality and integrity of data collected by paper. Also, eCOA tools allow both automatic and immediate score calculations during the study. This can be very useful to save significant amount of time especially when eCOA data are used for patient inclusion criteria.
And so, by always making the data attributable, legible, contemporaneous and accurate, eCOA solutions provide greater confidence in the data collected and allow time savings as compare to when the same data gets collected via paper forms.
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最終更新日 : 18 February 2020