What happens to coded verbatim terms when a user updates or clears the verbatim term or its associated context items?

The coding targets are automatically cleared, and the verbatim term is pulled back to Oracle Central Coding to be recoded.

  1. When a site user updates or clears the verbatim term or one of its associated context items (Route of administration or Indication), the coding targets on the study form are cleared.
  2. In turn, Oracle Central Coding retrieves the updated verbatim term so that it can be recoded based on the changes made.
  3. The coding targets are again populated after the verbatim term has worked its way through the coding process in Oracle Central Coding.
Additional details:
  • Route of administration refers to the method in which a drug was taken, and Indication defines why. For example, Aspirin (verbatim) was taken orally (route) for headache relief (indication).
  • Coding targets are read-only text fields on study forms, typically hidden in the UI for most study roles, that are populated with values from one of the dictionaries configured in Oracle Central Coding.

    The study designer, using the protocol, determines how many coding targets are needed for each form. After each verbatim term is coded, Oracle Central Coding sends dictionary values to populate the coding targets.

  • Typical medical coding study forms include:
    • Adverse Events
    • Concomitant Medications
    • Medical History

To view audit trail details for coding questions and coding targets, generate the Subject Data report.

Parent topic: Subject and data entry FAQs