Details about the Coding Question settings on the Advanced sidebar

Learn how to use the Dictionary, Coding Item Type, and Tag for Central Coding settings, located on the Advanced sidebar, when creating the verbatim term, context items, and coding targets.

Overview

The selections made from these settings are added to the mapping file used in the exchange of data between Oracle Clinical One Platform and Oracle Central Coding, and they help organize verbatim terms in Oracle Central Coding.

Setting Description
Dictionary
Select the dictionary that is configured in Oracle Central Coding for your study.
  • MedDRA, the Medical Dictionary for Regulatory Activities, is a standardized medical terminology used to classify and code medical information, such as adverse events and medical history, for subjects in clinical trials.

    Supported Languages: English (MedDRA) and Japanese (MedDRA/J)

  • WHODrug (WHO DD), the World Health Organization Drug Dictionary, is a global dictionary of medicinal information that contains data on trade names, active ingredients, and other product details for drugs used in human medicine. WHODrug is used to classify and code concomitant medications taken by subjects in clinical trials.

    Supported Languages: English, (???Chinese, Spanish, Portuguese???)

    Note: As of March 2017, the B3 and C3 formats are considered the standard for WHODrug Global. Oracle Central Coding still allows the use of the C and B2 formats, despite their official discontinuation in 2019.

  • JDrug: JDrug is a Japanese drug dictionary mainly used in the Japanese pharmaceutical industry and regulatory environment.
Coding Item Type

This drop-down is populated based on the dictionary selected.

Select the value from the drop-down that matches the question you created. For example, if you created a verbatim term question on the Adverse Event, Medical History, or Concomitant Medication forms, select Verbatim Term from the drop-down. Alternatively, if you created a coding target for Low Level Term Code, choose that option from the drop-down as well.
Tag for Central Coding These tags are used in Oracle Central Coding assignment rules to organize incoming verbatim terms into groups.
  • Select AE for the verbatim term question on your Adverse Event form.
  • Select DISEASE for the verbatim term question on your Medical History or Medical Procedures form.
  • Select NT-DISEASE for the verbatim term question on your Non-Target Disease form.
  • Select MEDPROD for the verbatim term question on your Concomitant Medications form.
  • LABDATA can be used as necessary to further distinguish between verbatim terms.

Parent topic: Form and validation rule FAQs