Overview of designing for integration
The InForm to Argus Safety integration automates the reporting of serious or clinically significant adverse events for a drug or a medical device by sites. You define the data to be sent to Argus Safety as well as which changes trigger a follow-up transmission using Central Designer data mapping. InForm Publisher monitors the InForm trial database and sends a message containing adverse events and other information such as medical history, concomitant medications, and labs to Argus Safety based on the time frames you configure in InForm Publisher or data entered into InForm.
Tip: See an infographic depicting the process of sending InForm safety data to Argus Safety.
To design a study for InForm to Argus Safety integration, use Central Designer to:
- Design the Adverse Event forms, other related forms (for example, Medical History, Concomitant Medications), and the Safety Case form and add items to be transmitted from InForm to Argus Safety.
- Add rules to the Adverse Event and Safety Case forms that trigger and direct the transmission of safety event data from InForm to Argus Safety.
- Map the InForm safety event data items to corresponding items in Argus Safety (the Safety Logical Schema).
- When triggered by specific data entered for a subject in InForm or on a configurable schedule, InForm Publisher pulls the selected data from InForm and sends it to Argus Safety using published web services interfaces according to the InForm Publisher configuration options you select.
An integration layer transforms the message to E2B+ format and writes the file to the Argus Interchange server where it is imported to the Pending E2B screen in Argus Safety. The Argus user can accept the file as a new case or reject the file.
For more information, about the integration, see the Integration Hub documentation.