Coding forms support multiple verbatim terms
Study designers can include multiple verbatim term fields on coding forms, eliminating the need to create separate forms to capture verbatim terms that must be coded to different dictionaries.
Details for study designers
Clinical One Cloud Service previously supported only one verbatim term field per coding form. As a result, study designers had to create separate forms whenever related information needed to be coded to different dictionaries. For example, a medical condition and its associated medication had to be captured on separate forms so that each verbatim term could be mapped to the appropriate coding dictionary.
- 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.
For more information, see the Study Designer User Guide after the assessment environment is upgraded.
Details for site users
- Each verbatim term is coded independently.
- A verbatim term can be coded without requiring the other verbatim term fields on the form to be completed.
- Only the corresponding coding targets are populated with the returned dictionary values.
Previously coded verbatim terms are also recoded independently. If a user edits one verbatim term, only that term is recoded. Only the corresponding coding targets are updated with the returned dictionary values.
Impact on existing studies
- This enhancement is available for new and existing studies. Before updating existing coding forms to include multiple verbatim term fields, evaluate the impact on your study design and ongoing data collection.
- Advanced Study Versioning (ASV) does not support coding mapping changes. To introduce multiple verbatim term fields into an existing study, use the standard study versioning process.
Parent topic: Integrations