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Data source verification is an ongoing challenge for registries and for sites.
A randomly assigned 1% sample of centres underwent audits for data source verification.
Beside this, visits will be organised in order to perform data source verification according to a monitoring plan.
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A data review tool enabled the monitor to identify missing data values, data values deviating from the normal range and among other things, data needing source verification.
The monitor will check completeness and plausibility of the data and will align the study data to the original data (Source Data Verification).
Although the analysis was conducted retrospectively, source verification of entered data was possible given the nature of data collection.
This will include a system of data checking, audit trails (detailed logs showing data which have been changed, the reason for any change, who made the change and when), and source verification procedures.
We have assumed that the triangulated result is the most accurate one, based on consistency of the data from different sources, verification by the participant, consistency within the IDI text when it is analysed in detail, numbers of returned gel applicators, and the absence of evidence to the contrary.
Chart data source: eMarketer.
Data source: U.S. National Weather Service, National Hurricane Center.
Data source: IBTrACS.
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