Last updated on MARCH 08, 2017
Applies to:Oracle Clinical Remote Data Capture Option - Version 4.6.0 and later
Information in this document applies to any platform.
Background: The PDR – used for submissions - includes the actual CRF, followed by ‘ancillary pages’ to present audit history and ‘overflow’. The overflow condition means the user has typed data into a field that exceeds the length of the visible window for the field (as designed by the customer). The field scrolls as the user enters data.
The bug in this case is that the overflow is not displaying the current, updated value for the field which included additional information. Rather it displays the initial value, excluding the more recent text. In this particular case, it appears that the text is being truncated.
Impact: Preventing an FDA audit from proceeding as needed. Also prevents Sites from seeing patient data for a Study after the study has been closed and RDC access removed for the Site personnel.
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