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
Vault calculates Dechallenge values on Case Assessments based on a combination of the E2B Codes on the Controlled Vocabularies corresponding to the Action Taken on the Case Product and the Outcome on the Case Adverse Event:
| Action Taken E2B Code | Outcome E2B Code | Dechallenge Value |
|---|---|---|
1 or 2 |
1, 2, or 4 |
Yes |
3 or 5 |
No | |
0 |
Unknown | |
0 |
Any | Unknown |
| Any other combination | Any other combination | Not Applicable |
If either the Outcome or Action Taken fields are blank or include a custom value, Vault does not populate a Dechallenge value.
Dechallenge Recalculation
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.