How Vault Calculates Dechallenge

Upon Case Assessment generation, Vault calculates Dechallenge values. For the calculation, Vault considers the following fields:

  • Outcome on Case Adverse Events
  • Action Taken on Case Products

You can override Vault-populated values using the Dechallenge Override field on Case Assessments. Vault exports Dechallenge and Dechallenge Override values to NMPA E2B(R3), CIOMS I, and FDA MedWatch 3500A files.

Dechallenge Calculation Criteria

Vault calculates and applies Dechallenge values on Case Assessments that meet all of the criteria as follows:

  • Dechallenge is Unknown when:
    • The Outcome of the Case Adverse Event is unknown
    • The Action Taken of the Case Product is one of:
      • Unknown
      • Drug withdrawn
      • Drug reduced
  • Dechallenge is Yes when:
    • The Outcome of the Case Adverse Event is one of:
      • recovered/resolved
      • recovering/resolving
      • recovered/resolved with sequelae
    • The Action Taken of the Case Product is one of:
      • Drug withdrawn
      • Drug reduced
  • Dechallenge is No when:
    • The Outcome of the Case Adverse Event is one of:
      • not recovered/not resolved/ongoing
      • Fatal
    • The Action Taken of the Case Product is one of:
      • Drug withdrawn
      • Drug reduced

For all other combinations of Outcome and Action Taken, Vault populates Not Applicable in the Dechallenge field. If either the Outcome or Action Taken fields are blank or include a custom value, Vault does not populate a Dechallenge value.

Assessment Dechallenge Recalculations

Vault recalculates Dechallenge values when you:

  • Add or edit:
    • Outcome on Case Adverse Events
    • Action Taken on Case Products
  • Run the Generate Assessments action
  • Unblind Case Products

Vault copies Dechallenge values instead of recalculating them when you:

  • Create follow-up Cases by running the Create Follow Up Case action
  • Bulk unblind Cases

Depending on your Admin’s configuration, when Vault recalculates Dechallenge values on Case Assessments with Dechallenge Override values, Vault may clear Dechallenge Override values.