As part of CTEP’s ongoing adoption of CDISC standards, the CTEP-AERS application will be taken offline and updated to support CDISC compliant data elements on the evening of Tuesday, November 19, 2019 at 8:30 – 11:30 PM EST. The changes are to labels in the application and on reports only.
When the difference between the existing CTEP-AERS label and the CDASH variable is minimal, CTEP-AERS will only display the CDASH variable. When the current CTEP-AERS label provides greater detail, it is retained and the CDASH variable is in parentheses following. For example, in the CTEP-AERS Agent section, the current CTEP-AERS label is “Agent Start Date” and the corresponding CDASH variable is “Exposure Start Date.” CTEP-AERS will display the following: Agent Start Date (Exposure Start Date).