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Fig. 3 | BMC Medical Research Methodology

Fig. 3

From: Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

Fig. 3

Common data elements for the reporting of SAEs. More than half of the data exporting sites have no SAE documentation available in their EHRs. This refers to the items ‘seriousness’, ‘action taken’, and ‘autopsy report in case of death’. Some sites have few data elements available but unclear whether data values are present apart from one where no data has been captured so far

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BMC Medical Research Methodology

ISSN: 1471-2288

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