CIOMS I (Chinese) Generation Data Mapping

Vault supports generating CIOMS I forms that are localized for submission to the National Health Commission (NHC) of China and for distribution to partners. To generate a Transmission using the CIOMS I (Chinese) report type, a Localized Case must include Chinese (China) in the Localization field. When you generate a CIOMS I (Chinese) form, Vault maps data, including data for region-specific fields, from the Localized Case where possible, and from the global Case otherwise. The labels on generated forms appear in Chinese.

Localized Form Data Mapping

When you generate a CIOMS I (Chinese) form, Vault maps data and documents to the applicable forms and fields using the CIOMS I mapping, with some exceptions. The following sections list the CIOMS I (Chinese) form fields that use different mapping than the global form equivalents.

I. Reaction Information

The following table lists Reaction Information section mapping specific to the CIOMS I (Chinese) form:

CIOMS I (Chinese) Field Data Source
1a. Country Vault populates the Code from the Localized Country corresponding to the Event Country on the Localized Case.
7 + 13 Describe Reaction(s) Vault populates:
  • From the Localized Case:
    • Narrative Preview
    • Reporter's Comments
    • Company Comments
  • From the Localized Case Cause of Death, the Cause of Death (Reported)
  • From the Localized Case Test Result:
    • Test Name (Reported)
    • Test Name (Coded)
    • Result (Text)
    • Comments
  • From the Case Adverse Event:
    • Based on the Outcome, the Name from the Outcome localized controlled vocabulary for China
    • Seriousness
  • Based on the Action Taken from the Case Product, the Name from the Action Taken localized controlled vocabulary for China
  • From the Case Test Result:
    • Date
    • Result
    • Result (Unit) localized based on the Localization of the Localized Case
    • Result (Code) localized based on the Localization of the Localized Case
    • Normal High Value
    • Normal Low Value

If the Narrative Preview text overflows onto additional pages, the Company Comments also overflow.

II. Suspect Product(s) Information

The following table lists Suspect Product(s) Information section mapping specific to the CIOMS I (Chinese) form:

CIOMS I (Chinese) Field Data Source
15. Daily Doses Vault populates:
  • From the Localized Case Product Dosage, the Dose Text
  • From the Case Product Dosage:
    • If both fields include values, the Dose (number) and Dose (unit) using the localized unit of measure
    • If both fields include values, the Frequency (number) and Frequence (unit) using the localized unit of measure
16. Route(s) of Administration Vault populates:
  • Localized Route of Administration values corresponding to the Patient RoA or Parent RoA on the Case Product Dosage
  • Patient RoA Text or Parent RoA Text on the Localized Case Product Dosage

For parent-child cases, Vault lists the routes of administration for both the patient (child) and the parent.
17. Indication(s) for Use The Name (Reported) on the Localized Case Product Indication.
19. Therapy Duration

If both fields include values, the Duration (number) and Duration (unit) using the localized unit of measure from the Case Product Dosage.

Vault exports Ongoing if the Action Taken on the Case Product is any of the following:

  • Dose reduced
  • Dose increased
  • Dose not changed

III. Concomitant Drug(s) and History

The following table lists Concomitant Drug(s) and History section mapping specific to the CIOMS I (Chinese) form:

CIOMS I (Chinese) Field Data Source
22. Concomitant Drug(s) and Dates of Administration Vault populates:
  • From the Case Product:
    • Based on the Drug Role, the Name from the Drug Role localized controlled vocabulary for China
    • PhPID
  • From the Localized Case Product, the Product (Reported)
  • From the Localized Case Product Indication, the Name (Reported)
  • From the Case Product Dosage:
    • First Administration date
    • Last Administration date
    • Duration (number)
    • Duration (unit) using the localized unit of measure
    • Dose Text (Long Text)
    • Dose (number)
    • Dose (unit) using the localized unit of measure
    • Frequency (number)
    • Frequency (unit) using the localized unit of measure
23. Other Relevant History Vault populates:
  • From the Case Medical History:
    • Condition / Procedure (LLT)
    • Start Date - End Date or Continuing
  • From the Localized Case, the Medical History Text