Previous Topic

Next Topic

Book Contents
Map multiple AE forms

If your study design contains secondary AE forms and collects AE and safety case data on a combined form, the InForm to Argus Safety integration supports transmitting safety event data from all AE forms. The integration does not support mappings for multiple AE forms when the study uses the model of separate AE and Safety Case forms.

  1. To create mappings for multiple AE forms, map the corresponding items from each AE form to the same data series.

    For example, if you have a primary AE form and a Pregnancy AE form:

    1. In the Safety_Config data set, map an item from the primary AE form and an item from the Pregnancy AE form to the Any AE Form Control data series. The InForm to Argus Safety integration uses this data series to identify the AE form or forms in the study.
    2. Optionally, map items from both the primary AE form and the Pregnancy item to the other data series.

      Note: To include form instances based on date range, as configured in InForm Publisher, you must map a date time item from the primary AE form and a date time item from the Pregnancy AE form to the AE Start Date Control data series.

  2. In the other data sets, map items from the primary AE form and the Pregnancy AE form to the applicable data series. For example, map the AE Start Date from each form to the AE_StartDateTime data series in the Subject_AdverseEvent data set.
Send Feedback