Language settings can be specified at individual trial level or at site level using Domain Value Maps in the AIA layer, which are discussed later in this document. The AIA layer generates an E2B+ file conforming to, or ich-icsr-v2.1-PMDA_PIP.dtd based on the language settings. Oracle Health Sciences InForm Publisher sends this initial message to the AIA layer. The subject number will be sent as the patient ID. The integration will always send Reported from Study as the report type. If this value is not entered and the product name is not entered on a form in Oracle Health Sciences InForm, the integration sends the string StudyDrug when any drug information is entered in Oracle Health Sciences InForm and StudyDevice when any device information is entered. If the product name is not mapped in the Logical Schema, the value in StudySponsorDrug field in the trial database will be sent as the Product Name for the Drug and/or Device product.

The Initial Received Date is the date in the time zone of the site when the adverse event was marked as serious or reportable. If qualification code for the reporter is not mapped to an item in the Safety Logical Schema or the value is not entered, the qualification code of the reporter will be sent as Physician. The name and address of the site where the subject experienced the adverse event is considered as the address.īased on the above details, the Safety user searches for the Principal Investigator of that site where the serious adverse event had occurred and enters the details of the Principal Investigator as the primary reporter of the case in Oracle Argus Safety. The Site mnemonic concatenated with the site name will display as the institution of the reporter in Argus. This user is considered the primary reporter of the case while sending the event details to Oracle Argus Safety. The full name of the user who marked the AE as serious or reportable. The following details are sent to Safety regarding the serious adverse event: There is some data that is pre-populated by the integration when sending the safety data. This last step is optional and can be disabled. Once the case is accepted or rejected either manually or automatically in Argus, the case ID, status, and rejection reason (if applicable) will be sent back to Oracle Health Sciences InForm. If not, the file will appear in the Pending E2B Reports screen in Argus. If auto-acceptance is configured in Argus, a case will be created.

The AIA layer will transform the message to an E2B+ file. For more details, see InForm Publisher On Demand 1.0.2.0 Installation Guide. This message will include adverse events, concomitant medications, and labs that fall into the time frames specified in Oracle Health Sciences InForm Publisher. Oracle Health Sciences InForm Publisher will monitor the InForm Trial database and send a message containing all the data items mapped in the Safety Logical Schema to the AIA layer. The Study Designer in Central Designer will define the items to be sent and the trigger to send the data. However, the following will always happen. The steps will differ based on the trial design. This integration automates the sending of serious adverse event data from the EDC system, Oracle Health Sciences InForm, to the safety system, Oracle Argus Safety.

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