Map items coded in Oracle InForm

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

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

   Tip:

   To make sure that the data sent to Argus Safety application is encoded in Oracle InForm, map the data series listed above in the Safety_Significant data set as well as in the Subject_AdverseEvent data set.
   When Oracle 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 Oracle Argus Safety receives the verbatim before the item is encoded in Oracle InForm, it attempts to encode the item and places the encoded values in the appropriate Oracle Argus Safety fields. When the external coding application returns encoded values to Oracle InForm, the updated values on the form trigger a follow-up to Oracle Argus Safety. An Oracle Argus Safety user can accept the follow-up. The Oracle InForm codes replace the Oracle 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:

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

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