Create forms for Oracle Central Coding

Use these guidelines to create forms for studies that use Oracle Central Coding.

Forms used with Oracle Central Coding, such as Adverse Events, Concomitant Medications, and Medical History, can be created as repeating forms or a two-section forms. For more information, see Create a repeating form and Create a form with two sections.

Forms created for use with Oracle Central Coding contain one or more verbatim term fields, optional coding context items for WHODrug coding, and coding targets.

Forms with multiple verbatim term fields:

• Each verbatim term field must be mapped to a different coding dictionary. For example, one verbatim term field can be mapped to a MedDRA dictionary and the other to a WHODrug dictionary.
• Each verbatim term field has its own coding targets to store the dictionary values returned by Oracle Central Coding.
• Each verbatim term is coded independently. This includes previously coded verbatim terms. If a user edits one verbatim term, only that term is recoded. Only the corresponding coding targets are updated with the returned dictionary values.
• A verbatim term can be coded without requiring the other verbatim term fields on the form to be completed.

Table 5-1 Components of a coding form

Component	Details
Verbatim term	A form field to capture a verbatim term, such as a medication like Ibuprofen, an adverse event like a headache, or a medical procedure like an Appendectomy. Depending on your study requirements, you can create a form with a single verbatim term field or multiple verbatim term fields mapped to different coding dictionaries.
Context items	Form fields used with WHODrug coding to capture Route of Administration and Indication. The Route of Administration captures the method of delivery for a drug, for example, orally, and the Indication defines why it was taken, for example, for migraine.
Coding targets	After a verbatim term is coded in Oracle Central Coding, the returned dictionary values populate the corresponding coding targets on the form.

• Create a question to capture a verbatim term
  Create a question to capture a verbatim term, such as a medication like Ibuprofen, an adverse event like a headache, or a medical procedure like an Appendectomy.
• Create the coding context items
  Create questions to capture the Route of Administration and Indication, often referred to as context items.
• Create the coding target fields
  Create the questions used in Clinical One Cloud Service to store dictionary values returned by Oracle Central Coding for coded verbatim terms.
• Details about the Coding Question settings on the Advanced sidebar
  Learn about the Dictionary, Coding Item Type, and Tag for Central Coding settings, available on the Advanced sidebar.
• Understand the data flow between Clinical One Cloud Service and Oracle Central Coding
  Learn how Clinical One Cloud Service and Oracle Central Coding exchange verbatim terms and coded dictionary values through automated schedules.