Sections in This Article
- About Blind Protection Relatedness Override for CIOMS I and E2B Generation
- Prerequisites
- Limitations
About Blind Protection Relatedness Override for CIOMS I and E2B Generation
Vault Safety has the ability to apply
blind protection
Blind protection activates after unblinding and masks sensitive information that could compromise the integrity of a study from unauthorized users.
for double-blinded Study Cases after you have unblinded them for CIOMS I and E2B documents. Once this feature is enabled, you can override the Case Assessment Results for these Study Cases using the Assessment Result (Override) field. The overriden value is exported in CIOMS I and E2B Transmission documents in place of the Assessment Result field value, including previews of the reports generated from the Case.
Prerequisites
Contact Veeva Support to request that this feature be made available in your vault.
Once this feature has been enabled in your vault, to make the override field available for data entry, add the field to one of the following page layouts:
- Case Page Layout:
Add the Assessment Result (Override) column to the Assessment Results section. - Case Assessment Result Page Layout:
Add the Assessment Result (Override) field to the Details section.
See Vault Help for more information on managing page layouts.
Limitations
There are two limitations when specifying an Assessment Result (Override) value.
- The system will always generate the masked version of aggregate reports.
- When the system attempts to map the record Name of the Assessment Result Controlled Vocabulary, it always finds the English record Name instead of the Localized record Name. For example, when the system maps to Result of Assessment for PMDA E2B(R3).
These limitations will be addressed in a future release.
