Term

Definition

Central Coding

Oracle application used to identify and apply appropriate codes to verbatim items.

code target

Coding dictionary construct that helps to classify data to be coded. Also, a corresponding form control holding data that has been coded.

context item

Coding dictionary construct that helps to classify context information for data to be coded. Also, a corresponding form control that provides additional information to enable coding of a verbatim. The WHODD dictionary uses context items to provide the following information:

• Route of Administration—The route by which the drug was administered.
• Indication—The disease or disorder for which the drug was taken.

dictionary

Standard thesaurus containing terminology used for coding. Central Coding supports the MedDRA and WHODD dictionaries.

InForm Adapter

Oracle application used to transfer verbatim and coded data between the InForm application and Central Coding.

MedDRA

Medical Dictionary for Drug Regulatory Activities—Standard thesaurus containing terminology applicable to all phases of drug development and to the health effects of devices.

verbatim

Form item holding data to be coded.

verbatim type

Specific type of verbatim defined in a coding dictionary. The following verbatim types are defined for the dictionaries supported by Central Coding:

• Valid in MedDRA:
  • AE—Adverse event
  • DISEASE—Disease
  • LABDATA—Lab data
• Valid in WHODD:
  • MEDPROD—Medical product

WHODD

World Health Organization Drug Dictionary—Standard thesaurus containing terminology about drugs.