Manage Case Blinding

If a blinded Case requires unblinding, such as SUSAR reporting, you can unblind the individual Case using the Unblinding Workflow.

About Case Blinding

Vault Safety protects sensitive information about blinded Study Products for Cases under a blinded Study, including Imported Case types.

When a serious and unexpected Case is suspected to have been caused by one of the Study Products, whether investigational or active comparator, you can unblind the Case to reveal the products.

When a Study Case is assessed as serious and unexpected (SUSAR) and confirmed during the Medical Review task, the system starts the unblinding workflow and assigns unblinding tasks to users in the Medical Reviewer role for the appropriate organization.

The unblinding workflow allows authorized users to see which product the patient was administered, whilst activating blind protection to ensure sensitive case data that would harm the integrity of the study remains hidden to users without access.

Vault Safety keeps track of which user breaks the blind and when in the Case audit trail.

This article describes how to unblind a single Case. For instructions to bulk unblind Cases during end of study reconciliation, see Bulk Unblind a Study.

Blind Protection After Unblinding

When you unblind a Case, Vault Safety activates blind protection. Blind protection continues to mask sensitive information that could compromise the integrity of the study from unauthorized users.

Only users with appropriate permissions can view blind-protected information. By default, only users assigned the Medical Reviewer or Head of Safety roles can access blind-protected information.

Blind protection masks the following information from unauthorized users:

• Case Products: The system continues to mask previously blinded Case Products.
• Case assessments: The system hides blind-protected Case Assessment records from unauthorized users.
• Generated reports: After unblinding a Case, the system hides generated individual case safety report documents from unauthorized users, such as E2B, CIOMS I, or FDA 3500A. Blind-Protection on Regulatory Report Previews provides more information.

Blind protection is not set on narrative documents by default, but can be set manually. See Blind Protection Field on the Narrative Document for more information.

Blind protection is not activated for E2B-imported Inbox Items, as it is handled by G.k.2.5 (Investigational Product Blinded).

Prerequisites

Refer to your organization’s standard operating procedure for the prerequisites to trigger the unblinding workflow in your Vault. In default configurations, the following requirements must be met before you can perform unblinding:

• The Medical Review task must have confirmed a seriousness assessment of serious and/or unexpected to trigger the unblinding workflow.
• In the standard configuration, users assigned the Medical Reviewer role can perform unblinding.

Unblind Study Products

You must unblind the blinded Study Product that is assessed to have caused a serious and unexpected adverse event before you submit an individual case safety report to the FDA.

When the Unblinding workflow starts, the system assigns a Case Product Unblinding task to the appropriate workflow participants.

Unblind a Product

1. Accept the Case Product Unblinding task.
2. In the Case Product Unblinding task banner, select Complete.
   The Unblinding window appears.
3. Under Verdict, select one of the following options:
   • Unblinded: Unblind the product.
   • Keep Blind: Maintain the product blind settings.
4. In the Comment field, enter any comments about the decision.
5. In the Study field, select the study that monitors the product.
6. In the Product (Study) field, select the product.
7. Select Complete.

Complete the Case Unblinding Task

The final step to complete Case unblinding is to perform the Case Unblinding task. When the Unblinding workflow starts, the system assigns a Case Unblinding task to the appropriate workflow participants.

Unblind a Case

1. Accept the Unblinding task.
2. Review the Case page to ensure the Case should be unblinded.
3. In the Unblinding task banner, select Complete. The Unblinding window appears.
4. Under Verdict, select Unblinded.
5. Enter your credentials in the User Name and Password fields.
6. In the Unblinded By field, select the role of the person who first unblinded the Case.
7. In the Unblinded Date field, enter the date when the Case was unblinded. If you are unblinding the Case for the first time, enter today’s date. If the Study was unblinded outside of Vault Safety, enter the date when unblinding occurred.
8. In the Unblinded Reason field, enter the reason for unblinding the case.
9. Select Complete.

Result

The Case is unblinded and advances to one of the following states:

• If the Case is flagged for expedited reporting, it moves to the Medical Review state.
• If the Case is not flagged for expedited reporting, it moves to the Approval state.

Maintain the Case Blind

1. Accept the Unblinding task.
2. Review the Case page to ensure the Case should remain blinded.
3. In the Unblinding task banner, select Complete. The Unblinding window appears.
4. Under Verdict, select Keep Blind.
5. In the Reason field, enter the reason for maintaining the case blind.
6. Enter your credentials in the User Name and Password fields.
7. (Optional) In the Seriousness field, edit the Case seriousness criteria.
8. Select Complete.

Result

The Case remains blinded and moves to the Approval state.