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Map items coded in InForm

If the InForm study is integrated with an external coding application, such as Central Coding, you can map the items so that the encoded data is transmitted to Argus Safety.

  1. Map the following data series to the corresponding AE description items, as identified in Which items have data series for transmitting encoded or verbatim data?:
    • AE_VerbatimTerm
    • AE_LowLevelTerm
    • AE_PreferredTerm
    • AE_LLTMedDRAVersion
    • AE_PTMedDRAVersion

    Tip Tip: To make sure that the data sent to Argus Safety application is encoded in InForm, map the data series listed above in the Safety_Significant data set as well as in the Subject_AdverseEvent data set.

    When Argus Safety receives an AE description, if all of the items mapped to these data series have data, it does not attempt to code the verbatim.

    However, if Argus Safety receives the verbatim before the item is encoded in InForm, it attempts to encode the item and places the encoded values in the appropriate Argus Safety fields. When the external coding application returns encoded values to InForm, the updated values on the form trigger a follow-up to Argus Safety. An Argus Safety user can accept the follow-up. The InForm codes replace the Argus Safety codes.

  2. Map the appropriate data series to the item containing the encoded MedDRA lower-level term. For example, map the ConMed_Indication data series to the lower-level term for the concomitant medication indication.

    Tip Tip: You can transmit either the verbatim or the encoded version, but not both. To transmit both, map the verbatim item and let Argus Safety encode it. See Map items coded in Argus Safety.

  3. Map the data series for the MedDRA version to the item containing the version of the MedDRA dictionary used to encode the item.

    Tip Tip: You can transmit either the verbatim or the encoded version, but not both. To transmit both, map the verbatim item and let Argus Safety encode it. See Map items coded in Argus Safety.

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