Configuring a study

  1. Select the Subscribers tab.
  2. In the tree, select the study to configure.
    The available configuration settings for the study appear on the right.
  3. Provide the following for the study:

    Table 3-3 Oracle Argus Safety and ODM Extract

    Field Description
    Study ID Not supported.
    Low Priority Thread? True or false, indicating the priority mode of the thread that publishes events:
    • True—Thread priority is low.
    • False (default)—Thread priority is normal.
    Run Startup Validation? This value should always be set to False.
    Language ID Not supported.

    Table 3-4 ODM Extract only

    Field Description
    Enable Audit If the endpoint type of the ODM Extract Publisher subscriber is CTMS, this option enables or disables storing messages sent from the Oracle InForm Publisher application in the audit table.

    Note:

    By default, this option is set to False.

    Table 3-5 Oracle Argus Safety only

    Field Description
    AE Range Starting Offset (days)

    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.

    • 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.

    Note:

    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 Staring Offset attribute must be set to -1.
    AE Range Ending Offset (days)

    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.

    • 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.

    Note:

    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 Ending Offset attribute must be set to -1.
    Lab Range Starting Offset (days)

    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.

    • 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.

    Note:

    If the Oracle InForm site user can select relevant labs, the Lab Range Starting Offset attribute must be set to -1.
    Lab Range Ending Offset (days)

    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.

    • 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.

    Note:

    If the Oracle InForm site user can select relevant labs, the Lab Range Ending offset attribute must be set to -1.
    ConMed Range Starting Offset (days)

    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.

    • 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.

    Note:

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

    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.

    • 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.

    Note:

    If the Oracle InForm site user can select relevant concomitant medications, the ConMed Range Ending Offset attribute must be set to -1.
    Oracle InForm Adapter URI Not supported.
    Oracle InForm user for Adapter Not supported.
    Oracle InForm user pwd for Adapter Not supported.
    Oracle InForm txn user for Adapter Not supported.
  4. Click Save.