The second analysis sought to determine if the container code entries in the eCRF that did not an IVRS assignment were possibly simple transcription errors. Error logs associated with drug shipment to sites were examined. on this comparison it became apparent that 76% of the incorrect container numbers (defined as those containers that did not match the IVRS assignment) captured in the eCRF were transcription errors (because the container did not exist at the site). The overall conclusion from these analyses was that the true proportion of errors in medication dispensations was therefore likely even lower than the 0.38% that was derived, based on eCRF entries.
The second analysis sought to determine if the container code entries in the eCRF that did not an IVRS assignment were possibly simple transcription errors. Error logs associated with drug shipment to sites were examined. on this comparison it became apparent that 76% of the incorrect container numbers (defined as those containers that did not match the IVRS assignment) captured in the eCRF were transcription errors (because the container did not exist at the site). The overall conclusion from these analyses was that the true proportion of errors in medication dispensations was therefore likely even lower than the 0.38% that was derived, based on eCRF entries.
auspar-apixaban-130621-cer.docx