Configure the Oracle Argus Safety-only attributes

Set up how Oracle InForm Publisher moves the adverse event data from Oracle InForm to Oracle Argus Safety. Perform these tasks after your work in Oracle Central Designer is complete, but before deploying your study to Oracle InForm.

Note:

Oracle InForm Publisher is installed as part of the Oracle InForm installation. For more information, see the Oracle InForm Installation Guide and the Configuration Guide for Oracle InForm Publisher.

1. Identify the Oracle Argus Safety-related attributes that apply to the study.

   Tip:

   • To configure time frames to trigger Oracle InForm Publisher to send safety data automatically, specify the number of days before and after the onset date of the adverse event (AE Range Starting Offset (days) and AE Range Ending Offset (days)) that Oracle InForm Publisher should use to include all Adverse Event forms started during the range or to include other forms associated with an adverse event.
   • If you are allowing the Oracle InForm site user to choose which AEs are relevant for sending to Oracle Argus Safety, instead of using time frames, you need to set AE Range Staring Offset and AE Range Ending Offset values to -1.
   • If the Oracle InForm site user can select relevant concomitant medications, set ConMed Range Starting Offset and Ending Offset to -1.
   • If the Oracle InForm site user can select relevant labs, set Lab Range Starting Offset and Ending offset to -1.
2. When you submit a ticket to Oracle Services to set up the integration with Oracle Argus Safety, communicate which attributes to include and their values.

Oracle creates the subscriber and populate its settings, and then adds the trial to the subscriber.

Field	Description
Argus Safety Only	-
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.
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.
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.
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.
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.
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.