# Manage Case Blinding 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.

Note: This page describes the default Vault Safety Unblinding workflow and protection settings. Follow your organization’s standard operating procedure for Case unblinding.

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. Typically, only users assigned the Medical Reviewer or Head of Safety roles can access blind-protected information.

Note: For Clinical Trial Study Cases, during Case unblinding, if all Study Products are unblinded, the Case-level Blinded field is automatically set to No.

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. Depending on your Admin's configuration, blind protection may be on for narrative documents to mask sensitive information and prevent unauthorized users from viewing the narrative. You can adjust blind protection for the narrative by updating the _Blind Protection_ document field value. 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

Note: For Studies without Study Arms, you must unblind each suspect product before you can unblind the Case. For Studies with Study Arms, you can directly unblind the Case without having to unblind individual 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.

Note: With default Vault configuration, after unblinding a Case with a Study Product that has a role of ‘Standard of Care’, the Case Blinded field is set to blank.

### 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.