1. User Guide
  2. Integrate Oracle InForm with Oracle Argus Safety
  3. About the Oracle InForm to Oracle Argus Safety integration
  4. Overview of designing for integration

Overview of designing for integration

AEs and SAEs are documented in Oracle InForm along with information about the event, such as medications taken and current status of the AE.

You can collect and transmit AE and SAE data using two types of forms:

  • Adverse Event forms
  • Safety Case forms

Note:

Oracle recommends that you set up and configure the Argus Safety integration for your study before you deploy your study to Oracle InForm.

When designing a study that uses the Oracle InForm to Oracle Argus Safety integration, you must do the following work in Oracle Central Designer:

  1. Design forms such as Adverse Event forms, other related forms, and (optionally) the Safety Case form.
  2. If desired, add items to the Safety Case forms using a dynamic grid. Using a dynamic grid allows Oracle InForm site users to manually select records that must be part of a safety case, based on their clinical judgment rather than simply relying on automated submissions.
  3. Add rules to the Adverse Event and Safety Case forms that trigger and direct the transmission of safety event data from Oracle InForm to Oracle Argus Safety.
  4. Map the Oracle InForm safety event data items to corresponding items in Oracle Argus Safety. Oracle InForm and Oracle Argus Safety use the data mapping feature of Oracle Central Designer to configure how safety event data items on Oracle InForm forms correspond to safety event entities in Oracle Argus Safety.
  5. Configure Oracle Argus Safety-only attributes to set up how Oracle InForm Publisher moves the adverse event data from Oracle InForm to Oracle Argus Safety.

Parent topic: About the Oracle InForm to Oracle Argus Safety integration