What data does the integration require?

For an E2B file to be accepted into Oracle Argus Safety as a new case, you must send the following data, at a minimum:

Adverse Event description—The site user can enter verbatim text to describe the adverse event triggering the case. If the site user does not supply text, the integration sends this description: "Event Description not Filled in by Oracle InForm User."

Report type—This is sent as "Report from Study."

Patient information—The SubjectNumber from Oracle InForm is sent as the Patient ID.

Reporter —The full name of the user that marked the adverse event as serious is sent as the Reporter. The Site Mnemonic and Name are sent as the reporter organization (displays in Institution field in Oracle Argus Safety) and the site address is the reporter address.

Suspect Product—You must send one. This can be collected on a form and mapped to MedicinalProductName. If not filled in or mapped, the value stored in the Oracle InForm database as SponsorStudyDrug is sent. If this is not populated and items were mapped to the SuspectDrug data series of the Safety Logical Schema, the string "StudyDrug" is sent.

Study Drug—The study drug must be sent to Oracle Argus Safety. You can add it to a form as and map it to Suspect Product in Oracle Argus Safety. Or, you can enter the study drug name under Sponsor Drug Name as a property of a Study Design object. Oracle InForm Publisher will send it automatically.

Country of Incidence or Reporter—Send either Country of Incidence or Reporter (also known as Primary Source Country).

• Country of Incidence can be mapped in the SafetyCase data series of the Logical schema.
• Primary Source Country comes from the country specified in the site address in InForm.
• If neither of these is available when the message is sent, Oracle Argus Safety rejects the E2B file.