Understand the options for creating a coding question and coding targets

Learn more about the options available in the system to define a coding question and its coding targets.

Below are listed the available options that you can select in the User Interface (UI) for each field required to configure a coding question: Dictionary, Coding Item Type, and Tag for Central Coding.

Caution:

While the documentation for coding questions is regularly updated, make sure you check the user interface first to see the exact list of options available for selection. If you notice a discrepancy in the documentation, let us know at clinical_one_doc_feedback_us_grp@oracle.com!

Dictionary

From this drop-down, you select the dictionary that is used by Oracle Central Coding to search for the term that you want to convert.

Dictionary Description
MedDRA Medical Dictionary for Regulatory Activities (MedDRA) is the dictionary used for adverse events and medical history of subjects.
WHODrug World Health Organization Drug Dictionary is the dictionary used for concomitant medications that subject take during a study.
WHO DD B2 The WHO-DD B2 is another version of the WHO Drug Dictionary (WHO-DD).
WHO DD B3 The WHO-DD B3 is another version of the WHO-DD dictionary.
WHO DD C The WHO-DD C is yet another specific format within the WHO Drug Dictionary system.
WHO DD C3 The WHO-DD C3 is a variation of the WHO-DD C dictionary type.
MedDRAJ The MedDRAJ refers to the Japanese version of the MedDRA dictionary.
JDrug JDrug is a Japanese drug dictionary mainly used in the Japanese pharmaceutical industry and regulatory environment.

Coding Item Type

The Coding Item Type identifies a question for coding mapping. The options you see in this drop-down depend on the selection you make for the Dictionary field above.

Associated dictionary Corresponding coding item types
MedDRA
  • Verbatim Term
  • System Organ Class Term
  • High Level Group Term
  • High Level Term
  • Preferred Term
  • Low Level Term
  • System Organ Class Code
  • High Level Group Code
  • High Level Term Code
  • Preferred Term Code
  • Low Level Term Code
  • International Agreement Order
  • Dictionary Name
  • Coder Name
  • Approver Name
WHO DD B2
  • Verbatim Term
  • Indication
  • Route of Administration
  • ATC1 Term
  • ATC2 Term
  • ATC3 Term
  • ATC4 Term
  • ATC1 Code
  • ATC2 Code
  • ATC3 Code
  • ATC4 Code
  • Preferred Name Term
  • Trade Name Term
  • Preferred Name Code
  • Trade Name Code
  • Ingredients
  • Base Substance Code
  • Base Substance Name
  • Dictionary Name
  • Coder Name
  • Approver Name
WHO DD B3 The same options displayed for WHO DD B2 are displayed for the WHO DD B3 dictionary version, as well.
WHO DD C The same options displayed for WHO DD B2 and WHO DD B3 are diplayed for the WHO DD C dictionary version, as well. Additionally, the following options are displayed:
  • Name Specifier
  • Country of Sale
  • MA Holder Country
  • Company
  • Company Country
  • ICH Med Prod ID
  • Sequence Number 3
  • Sequence Number 4
  • MA Number
  • MA Date
  • MA Withdrawal Date
  • Product Type
  • Product Group
  • Pharmaceutical Product
WHO DD C3 The same options displayed for WHO DD C are diplayed for the WHO DD C3 dictionary version, as well.
MedDRAJ The same options displayed for MedDRA are diplayed for the MedDRAJ dictionary version, as well.
JDrug
  • Verbatim Term
  • Indication
  • Route of Administration
  • TC1 Term
  • TC1 Code
  • TC1 (Kana)
  • TC2 Term
  • TC2 Code
  • TC2 (Kana)
  • TC3 Term
  • TC3 Code
  • TC3 (Kana)
  • TC4 Term
  • TC4 Code
  • TC4 (Kana)
  • Generic Name Term
  • Generic Name Code
  • Generic Name (Kana)
  • Generic Synonym Flag
  • Generic Use Class 1
  • Generic Use Class 2
  • Generic Common Name
  • Generic Common Name (Kana)
  • Generic Dosage Forms
  • Generic Drug Class 1
  • Trade Name Term
  • Trade Name Code
  • Trade Name (Kana)
  • Trade Synonym Flag
  • Trade Use Class 1
  • Trade Use Class 2
  • Trade Common Name
  • Trade Common Name (Kana)
  • Trade Dosage Forms
  • Trade Drug Class 1
  • Manufacturer Code
  • Manufacturer Abbreviation
  • Case Name Term
  • Case Name Code
  • Case Name (Kana)
  • Case Type
  • Dictionary Name
  • Coder Name
  • Approver Name

Tag for Central Coding

From this drop-down, you select a tag that categorizes your data in Oracle Central Coding.

Tag for Central Coding Description
AE Identifies the verbatim term as an adverse event.
DISEASE Identifies the verbatim term as medical history.??
NT-DISEASE ??
MEDPROD Identifies the verbatim term as concomitant medication. ??
LABDATA Identifies the verbatim term as lab data.

Related Topics

Parent topic: Form and validation rule FAQs