Oracle Argus Safety only attribute

AE range starting and ending offsets

If the Oracle InForm site user can choose which AEs are relevant for sending to Oracle Argus Safety, instead of using time frames, the AE Range Starting Offset and AE Range Ending Offset attributes must be set to -1.

  • AeRangeStartingOffset—Number of days before the onset date of an adverse event that the Oracle InForm Publisher application should consider when determining which Adverse Event (AE) forms (in addition to the AE form on which the adverse event was reported) are associated with the adverse event. If an instance of a related AE form has a start date within the range specified in the AeRangeStartingOffset and AeRangeEndingOffset settings, the safety event data from the related form is transmitted to the Oracle Argus Safety application. The default value is 14.

    This attribute is for Oracle Argus Safety type subscribers only. It is not required for trials added to ODM Extract type subscribers.

    • To include all AE forms that were started before the AE onset date, enter -1.
    • To include no AE forms that were started before the AE onset date, enter 0.
  • AeRangeEndingOffset—Number of days after the onset date of an adverse event that the Oracle InForm Publisher should consider when determining which Adverse Event (AE) forms are associated with the adverse event. If an instance of a related AE form has a start date within the range specified in the AeRangeStartingOffset and AeRangeEndingOffset settings, the safety event data from the related form is transmitted to the Oracle Argus Safety application. The default value is 14.

    This attribute is for Oracle Argus Safety type subscribers only. It is not required for trials added to ODM Extract type subscribers.

    • To include all AE forms that were started after the AE onset date, enter -1.
    • To include no AE forms that were started after the AE onset date, enter 0.

ConMed range starting and ending offsets

If the Oracle InForm site user can select relevant concomitant medications, the ConMed Range Starting Offset and Ending Offset attributes must be set to -1.

  • ConMedRangeStartingOffset—Number of days before the onset date of an adverse event that the Oracle InForm Publisher application should consider when determining which Concomitant Medication (ConMed) forms are associated with the adverse event. If an instance of a related ConMed form has a start date within the range specified in the ConMedRangeStartingOffset and ConMedRangeEndingOffset settings, the safety event data from the related form is transmitted to the Oracle Argus Safety application. The default value is 14.

    This attribute is for Oracle Argus Safety type subscribers only. It is not required for trials added to ODM Extract type subscribers.

    • To include all ConMed forms that were started before the AE onset date, enter -1.
    • To include no ConMed forms that were started before the AE onset date, enter 0.
  • ConMedRangeEndingOffset—Number of days after the onset date of an adverse event that the Oracle InForm Publisher application should consider when determining which Concomitant Medication (ConMed) forms are associated with the adverse event. If an instance of a related ConMed form has a start date within the range specified in the ConMedRangeStartingOffset and ConMedRangeEndingOffset settings, the safety event data from the related form is transmitted to the Oracle Argus Safety application. The default value is 14.

    This attribute is for Oracle Argus Safety type subscribers only. It is not required for trials added to ODM Extract type subscribers.

    • To include all ConMed forms that were started after the AE onset date, enter -1.
    • To include no ConMed forms that were started after the AE onset date, enter 0.

Lab range starting and ending offsets

If the Oracle InForm site user can select relevant labs, the Lab Range Starting Offset and Ending Offset attributes must be set to -1.

  • LabRangeStartingOffset—Number of days before the onset date of an adverse event that the Oracle InForm Publisher application should consider when determining which Lab forms are associated with the adverse event. If an instance of a related Lab form has a start date within the range specified in the LabRangeStartingOffset and LabRangeEndingOffset settings, the safety event data from the related form is transmitted to the Oracle Argus Safety application. The default value is 14.

    This attribute is for Oracle Argus Safety type subscribers only. It is not required for trials added to ODM Extract type subscribers.

    • To include all Lab forms that were started before the AE onset date, enter -1.
    • To include no Lab forms that were started before the AE onset date, enter 0.
  • LabRangeEndingOffset—Number of days after the onset date of an adverse event that the Oracle InForm Publisher application should consider when determining which Lab forms are associated with the adverse event. If an instance of a related Lab form has a start date within the range specified in the LabRangeStartingOffset and LabRangeEndingOffset settings, the safety event data from the related form is transmitted to the Oracle Argus Safety application. The default value is 14.

    This attribute is for Oracle Argus Safety type subscribers only. It is not required for trials added to ODM Extract type subscribers.

    • To include all Lab forms that were started after the AE onset date, enter -1.
    • To include no Lab forms that were started after the AE onset date, enter 0.

Unsupported attributes

  • InFormAdapterUri—Not supported.
  • InFormAdapterTransactionUser—Not supported.