# Isolate Blinded Clinical Trial Information

The Clinical Trials: Isolate Blinded Product Information feature offers Vault's most advanced approach to protecting blinded information for clinical trial study _Cases_. We recommend adopting this feature to ensure optimal processing of your blinded clinical trial study _Cases_ from start to finish. This feature offers the following significant advantages over other methods of managing _Case_ blinding:

* Dual records preserve all of the information from before and after unblinding for all global and localized records
* Support for independent assessments of unblinded _Case Products_ during the medical review process
* Blind protection supports overall clinical trial integrity when distributing SUSARs to ethics committees and study sites
* Accurate reporting to both regulatory and non-regulatory health authorities
* A clear user interface to help users easily differentiate blinded from unblinded information
* [Expectedness][5] generation for blinded study products.

### Prerequisite

Your Admin must <a href="/en/lr/691318/">enable Clinical Trials: Isolate Blinded Product Information</a>.

### <a id="overview"></a>Overview

For blinded clinical trial study _Cases_, Vault initially creates one (1) set of records with the _Blinding Type_ set to _Blinded_. Blinded records store information that is not blind-sensitive.

Vault considers the following _Study_-related object fields blind-sensitive:

<table>
    <thead>
        <tr>
            <th>Object</th>
            <th>Fields</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Case Product</em></td>
            <td><ul>
            <li><em>Product Coded</em></li>
            <li><em>Product</em></li>
            <li><em>Study Product</em></li>
            <li><em>Name</em></li>
            <li><em>Combination Product</em></li>
            <li><em>Lot Number</em></li>
            <li><em>Model Number</em></li>
            <li><em>MPID</em></li>
            <li><em>Product Registration</em></li>
            <li><em>Serial Number</em></li>
            <li><em>Study Arm Product</em></li>
            <li><em>Substances</em></li>
            <li><em>Trade Name</em></li>
            <li><em>Unique Identifier</em></li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Case Product Dosage</em></td>
            <td><ul>
            <li>All</li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Case Product Substance</em></td>
            <td><ul>
            <li>All</li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Case Product Registration</em></td>
            <td><ul>
            <li>All</li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Case Assessment</em></td>
            <td><ul>
            <li><em>Name</em></li>
            <li><em>Expected</em></li>
            <li><em>Expected (status)</em></li>
            <li><em>Listedness</em></li>
            <li><em>Listedness (status)</em></li>
            <li><em>Reaction Recurrence</em></li>
            <li><em>Dechallenge</em></li>
            <li><em>Dechallenge Override</em></li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Case Assessment Expectedness</em></td>
            <td><ul>
            <li>All</li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Case Assessment Result</em></td>
            <td><ul>
            <li><em>Assessment Result Override</em></li>
            <li><em>Causality Established</em></li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Localized Case Product</em></td>
            <td><ul>
            <li><em>Local MPID</em></li>
            <li><em>Product (Coded)</em></li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Localized Case Product Dosage</em></td>
            <td><ul>
            <li>All</li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Localized Case Product Substance</em></td>
            <td><ul>
            <li>All</li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Localized Case Assessment</em></td>
            <td><ul>
            <li>All</li>
            </ul></td>
        </tr>
        <tr>
            <td><em>Localized Case Assessment Result</em></td>
            <td><ul>
            <li><em>Result (text)</em></li>
            </ul></td>
        </tr>
    </tbody>
</table>

If you unblind a _Case_, Vault isolates the unblinded from the blinded information by creating a second set of these records. To create the unblinded records, Vault copies the values from the blinded records. The unblinded records have the _Blinding Type_ set to _Unblinded_ and include a reference to the blinded record in the _Blinded Reference_ field. The previously existing blinded records are unchanged in this process. Only users with the appropriate permissions can view unblinded records.

To unblind _Cases_ all at once, see <a href="/en/lr/774502/">Bulk Unblind Isolated Blinded Product Information</a>.

### <a id="switch-view"></a>Select the Blinded or Unblinded View

Vault maintains a clear separation between blinded and unblinded data through _Action Layout_ views. Isolating data assists Medical Reviewers in quickly identifying which type of information they are viewing. Users with appropriate permissions for viewing unblinded information can switch between the views of the _Case_.

To switch between views, go to the <a href="/en/lr/44069/#navigation-panel">_Navigation Panel_</a> and select either the blinded or unblinded view.

### <a id="type-reference"></a>Blinding Type and Blinded Reference

To identify the type of blinding on an object, refer to the _Blinding Type_ field, which Vault sets to one (1) of the following:

* _Blinded_
* _Unblinded_
* _Open_
* blank (for example, non-<em>Study</em> or _External Products_)

In addition, on records with a _Blinding Type_ of _Unblinded_, Vault populates the _Blinded Reference_ field with a link to the associated blinded record.

## Promoting Inbox Items for Clinical Trial Cases {#promote}

When promoting _Inbox Items_ for blinded clinical trial study _Cases_, Vault generates blinded and unblinded records based on the _Drug Role_ and _Blinded_ field values on the _Study Product_. Depending on your Admin's configuration, for _Products_ with a _Drug Role_ of _Suspect_, _Interacting_, or _Drug Not Administered_, Vault considers the _Blinded_ field value of the _Study Product_ on the _Inbox Item_ as follows:

* If set to _Blinded_, the promoted _Case_ includes blinded records only and the _Blinding Type_ is set to _Blinded_.
* If set to _Unblinded_, the promoted _Case_ includes both blinded and unblinded records as follows:
    * On blinded records, the _Blinding Type_ is _Blinded_.
    * On unblinded records, the _Blinding Type_ is _Unblinded_ and the _Blinding Reference_ field references the blinded record.
    * The _Case Product_ and _Product Registration_ is set using the _Study Product_ and _Product Registration_ on the _Inbox Item_.
* If set to _Open-Label_, the _Blinding Type_ is _Open_.

If the primary _Case Product_ is unblinded, the primary _Case Product_ is set on the blinded record, not the unblinded record.

### Study Product Lifecycle States

After _Inbox Item_ promotion, Vault sets _Study Product_ lifecycle states as follows:

<table>
    <thead>
        <tr>
            <th>Study Scenario</th>
            <th>Product Blinding</th>
            <th>Lifecycle State</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td rowspan="3">Blinded Study with blinded Study Arms</td>
            <td>Blinded</td>
            <td>Blinded</td>
        </tr>
        <tr>
            <td>Unblinded</td>
            <td>Unblinded</td>
        </tr>
        <tr>
            <td>Open</td>
            <td>Open</td>
        </tr>
        <tr>
            <td>Blinded Study with open Study Arms</td>
            <td>Open</td>
            <td>Open</td>
        </tr>
        <tr>
            <td>Open Study with open Study Arms</td>
            <td>Open</td>
            <td>Open</td>
        </tr>
        <tr>
            <td>Open Study Products</td>
            <td>Open</td>
            <td>Open</td>
        </tr>
        <tr>
            <td rowspan="3">Unblinded Study</td>
            <td>Blinded</td>
            <td>Blinded</td>
        </tr>
        <tr>
            <td>Unblinded</td>
            <td>Unblinded</td>
        </tr>
        <tr>
            <td>Open</td>
            <td>Open</td>
        </tr>
    </tbody>
</table>

## Unblinding Information

After <a href="/en/lr/01172/">medical review</a>, Medical Reviewers may unblind _Study Products_ if needed. Unblinding can occur when the following conditions are met:

* The _Study Product_ has a _Drug Role_ of _Suspect_, _Interacting_, or _Drug Not Administered_
* The _Study Product Placeholder_ field is populated

After unblinding, unblinded records can be viewed only by users with the appropriate permissions.

You can unblind _Study Products_ by:

* Running the [_Unblind Study Product_ action][6] to unblind all blinded _Study Products_ at once. We recommend this option when processing _Cases_ for _Studies_ without _Study Arms_.
* Unblinding individual _Study Products_ through the <a href="/en/lr/01176/#unblind-study-products">_Case Product Unblinding_ task</a>.

### <a id="unblind-sp"></a>Unblind Study Products

If your Admin has enabled <a href="/en/lr/826706/">Blind Isolation: Simplified Study Product Unblinding</a>, you can quickly unblind all blinded _Study Products_ on a clinical trial study _Case_. From the **All Actions** menu, select **Unblind Study Product**. Depending on your Admin's configuration, _Study Product_ unblinding may occur automatically as part of a workflow.

When _Study Products_ are unblinded, for all _Case Products_ with a [blinded record][7] only, if the _Blinding Type_ field value is _Blinded_, Vault:

* Creates an unblinded _Case Product_ record that includes the related _Dosage_ and _Indication_ records. On the new record, Vault leaves the _Product (reported)_, _Rank_, and _Primary_ fields, as well as blind-sensitive fields, blank.
* Creates unblinded versions of the related _Case Assessment_ and _Case Assessment Result_ records.

### Blinded and Unblinded Records

After <a href="/en/lr/01176/#complete-the-case-unblinding-task">completing the _Case Unblinding_ task</a>, Vault retains the blinded records and, for each blinded record, creates an unblinded record. The default record detail page displays the unblinded records, but you can <a href="#switch-view">switch between the blinded and unblinded views</a>.

Complete unblinding on unblinded records.

Consider the following when working with blinded and unblinded records:

* For _Case Products_ on blinded domestic study _Cases_ for Japan, when the _Retrieve Reportable Case Product Registrations_ action is run, Vault generates _Case Product Registrations_ based on the _Blinding Type_. For example, for unblinded _Case Products_, Vault generates unblinded _Case Product Registration_ records only. For blinded _Case Products_, Vault generates blinded _Case Product Registration_ records only.
* On _Case Product Registration_, _Localized Case Assessment_, and _Localized Case Assessment Result_ records, the _Blinded Reference_ field is always blank on unblinded records. This supports submitting blinded information to the PMDA when required.
* _Substance_ and _Dosage_ records do not exist on blinded Study Cases. During unblinding, unblinded _Dosage_ and _Substance_ records are created, but no blinded records are created. Therefore, the _Blinded Reference ID_ field remains blank, instead of referencing a blinded record.
* On blinded records, you cannot enter information in [blind-sensitive fields][3] if an unblinded record exists. For the following exceptions to this rule, Vault does not sync changes on blinded records to unblinded records:
    * Blinded _Case Product Dosages_
    * The _Dechallenge_ or _Dechallenge Override_ fields on blinded _Case Assessments_
* During unblinding, if your Admin has configured your Vault to populate non-blind-sensitive fields on _Case Products_ upon unblinding, on newly created unblinded _Case Product_ records, Vault clears populated values. This is a known limitation.
    * Optionally, you can re-enter cleared values, and then Vault updates both the blinded and unblinded records.

### Blind Protection for Open-Label Device Constituents

Vault protects the blind for _Combination Products_ that include open-label device constituents. If a user populates the _Combination Product_ field after unblinding a _Case Product_ record, Vault adds related constituent _Products_ as separate _Case Products_. When any constituent of a _Combination Product_ has the _Blinding Type_ set to _Unblinded_, Vault sets the _Blinding Type_ of all constituent products, including open-label products, to _Unblinded_. In addition, Vault sets the _Blinding Type_ and lifecycle state for all associated child records to _Unblinded_.

## Case-Level Roll-Ups

At the _Case_ level, Vault rolls up most evaluations based on blinded _Case Assessment_ records. The exception is _Case Blinded_, which is based on the _Blinded Type_ field across all _Products_ on the study _Case_. Rolling up from the blinded record ensures users without the required permission do not see unblinded information.

Roll-ups apply to the following _Case_-level fields:

* _Case Blinded_
* _Case Tags_ (This value rolls up from the more conservative of the blinded or open record.)
* _Expected (status)_
* _Case Expectedness_
* _Expedited_
* _Listedness (Core)_
* _Listedness (status)_
* _Relatedness_

## Updating Case Products

Use the <a href="/en/lr/01287/#products-section">_Case Products_ section</a> to manually add, edit, and delete products on blinded clinical trial study _Cases_. When the _Drug Role_ is _Suspect_, _Interacting_, or _Drug Not Administered_, Vault updates records as follows:

<table>
    <thead>
        <tr>
            <th>Action</th>
            <th>Blinded Case</th>
            <th>Unblinded Case</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Add Product</td>
            <td>Study Case Product created with <strong>Blinding Type</strong> set to <strong>Blinded</strong>.</td>
            <td>Study Case Product created with <strong>Blinding Type</strong> set to <strong>Unblinded</strong> and a reference to the blinded record in the <strong>Blinded Reference</strong> field.</td>
        </tr>
        <tr>
            <td>Edit Product</td>
            <td>No change to the <strong>Blinding Type</strong> of <strong>Blinded</strong>.</td>
            <td>No change to the <strong>Blinding Type</strong> of <strong>Unblinded</strong> or the <strong>Blinded Reference</strong> value.</td>
        </tr>
        <tr>
            <td>Delete Product</td>
            <td>See <a href="#cascade-delete">Deleting Case Records</a>.</td>
            <td>See <a href="#cascade-delete">Deleting Case Records</a>.</td>
        </tr>
    </tbody>
</table>

### Deleting Case Records {#cascade-delete}

If your Admin has configured your Vault to <a href="/en/lr/15057/#relationships_deletion">cascade the deletion of parent records to the associated child records</a>, Vault applies the following logic to record deletion:

* When unblinded study <a href="/en/lr/917562/#delete-cp">_Case Products_ and their related records are deleted</a>, Vault does not delete the associated blinded records. 
* Other than unblinded study _Case Products_, deleting unblinded records also deletes the associated blinded records.
* Blinded records cannot be deleted if they are referenced on an unblinded record.
* When global records are deleted, the associated localized records are also deleted.

Otherwise, each related record must be deleted manually.

## <a id="expect-evals"></a>Expectedness Evaluations for Study Product Placeholders

If your Admin has enabled <a href="/en/lr/774366/">Datasheet Expectedness for Blinded Study Products</a>, Vault generates expectedness for blinded _Study Products_ on blinded _Cases_ for double-blinded clinical trial _Studies_ without _Study Arms_. Learn more about how to <a href="/en/lr/01198/#assoc-datasheets">associate _Datasheets_ with _Study Product Placeholders_</a> and how Vault generates blinded and unblinded <a href="/en/lr/822874/#study-product-placeholder-expectedness">Study Product Placeholder Expectedness</a>.

## Creating Follow-Up or Merging to Current Study Cases

When creating follow-up or merging to current clinical trial study _Cases_ through the _Inbox Item to Case Compare_ page, Vault generates blinded and unblinded records based on the _Blinded_ field setting of the previous _Case_ version as follows:

* If set to _Blinded_, Vault generates blinded records only and sets the _Blinding Type_ to _Blinded_.
* If set to _Unblinded_, Vault generates both blinded and unblinded records as follows:
    * On the blinded record, the _Blinding Type_ is set to _Blinded_.
    * On the unblinded record, the _Blinding Type_ is set to _Unblinded_, and the _Blinding Reference_ field references the blinded record.
    * The _Case Product_ on the blinded record is set to _Rank_ `1`. The unblinded version of the record is left blank. For products other than the primary _Product_, the unblinded and blinded records share the same rank.

If the _Blinding Type_ setting on the _Inbox Item_ and the matched _Case_ are different, Vault generates records as follows:

* If the _Inbox Item_ is unblinded and the matched _Case_ is blinded, Vault generates both blinded and unblinded records.
* If the _Inbox Item_ is blinded and the matched _Case_ is unblinded, Vault retains the unblinded information from the existing unblinded records. In addition, information that is not blind-sensitive is added to the blinded records and synched to the unblinded records.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: You cannot run the <em>Promote to Follow-Up</em> or <em>Merge to Current</em> actions on a matched <em>Case</em> that includes only unblinded records. Contact your Admin to generate the required dual records on the matched <em>Case</em>.</p>
    </div>
  </div>
</div>



### Case Compare

When promoting or merging _Inbox Items_ to matched _Cases_, the _Inbox Item to Case Compare_ page displays blinded and unblinded records as follows:

* For blinded _Cases_, the blinded records are shown to all users.
* For unblinded _Cases_ with blind protection, records with a _Blinding Type_ of _Open_, _Blinded_, or blank are visible to all users. If at least one (1) record is set to the _Blinding Type_ of _Unblinded_, those unblinded records are shown to users with permissions to view unblinded information.
* For unblinded _Cases_ without blind protection, all users can see records with any _Blinding Type_.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: For unblinded Inbox Items, blinded records will not be displayed on the <em>Inbox Item to Case Compare</em> page because Vault generates them during <em>Case</em> creation.</p>
    </div>
  </div>
</div>



When a matched _Case_ includes both a blinded and unblinded version of a record, you cannot delete any part of that set on the _Inbox Item to Case Compare_ page.

For information on how the Isolate Blinded Clinical Trial Information feature affects _Case_ selection on the _Case Version Compare_ page, see <a href="/en/lr/735242/">Case Version Compare</a>.

#### Different Blinding Types

Where _Blinding Type_ differs between an _Inbox Item_ and a matched _Case_, when using the record selection drop-down on the _Inbox Item to Case Compare_ page, Vault displays `(Type mismatch)` in the record label. Mismatched values cannot be selected.

### Case Assessment Results

After promoting or merging an _Inbox Item_ to an unblinded _Case_, if your organization uses the _Assessment Result (Override)_ field, Vault generates the new or updated _Case Assessments_ as follows:

* On the blinded record, Vault populates the _Assessment Result_ field and clears the _Assessment Result (Override)_ field.
* On the unblinded record, if populated on the previous _Case_ version, Vault populates the _Assessment Result (Override)_ value in the _Assessment Result_ field.

If the follow-up information includes a new _Case Product_ or _Case Adverse Event_, after promotion through the _Inbox Item to Case Compare_ page users can enter assessment-related values on _Case Assessment Results_ on the resulting blinded records. Vault prevents edits to the _Blinding Type_ and _Blinded Reference_ fields. Enabling users to enter _Case Assessment Result_ values on blinded records, which we recommend is done before entering them on unblinded records, supports unbiased assessments for the newly added _Case Product_ or _Case Adverse Event_.

If your Admin has enabled <a href="/en/lr/774366/">Datasheet Expectedness for Blinded Study Products</a>, when creating follow-ups or merging to existing _Cases_, if the _Blinded Name_ on the _Inbox Item_ doesn't match the previous _Case_ version, after promotion Vault regenerates all _Case Assessment_, _Case Assessment Result_, and _Case Assessment Expectedness_ records to reflect the latest associated _Datasheets_ for the new _Study Product Placeholder_. Vault deletes generated or overridden _Case Assessments_ for the previous _Study Product Placeholder_.

## Domestic Case Regeneration

If a domestic _Case_ was not successfully generated after promoting an _Inbox Item_ or if you add a _Localization_ to a global _Case_ to convert it to a domestic _Case_, you can generate the _Case_ and all child records in a single action. On the _Localized Case_, from the **All Actions** menu select **Re-generate Domestic Case**.

In addition to generating the expected _Case_ and child records, Vault populates the _Blinding Type_ and _Blinded Reference_ fields.

## How Unblinding Works with Reporting Rules and Transmissions

The following sections outline how the Clinical Trials: Isolate Blinded Product Information feature impacts masking on general and cross reports.

Vault applies reporting rules to blinded clinical trial study _Cases_ depending on your Admin's configuration. For general information on the reporting rules, see <a href="/en/lr/01256/">Understand the Reporting Rules Engine</a>.

### Submissions

By default, the Safety Reporting Rule Engine does not generate _Submissions_ for blinded _Products_. When _Products_ are unblinded, the reporting rule engine evaluates reporting obligations to generate _Submissions_.  


<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: 
Your Admin can configure <a href="/en/lr/01213/#blinded-product-selection"><em>Blinded Product Selection</em></a> for any agency that requires blinded Serious Adverse Event (SAE) reporting.</p>
    </div>
  </div>
</div>



Vault populates report fields with unblinded _Submission_ content based on the _Study Content Protection_ field on the _Partner Distribution List_ as follows:

<table>
    <thead>
        <tr>
            <th>Study Content Protection Setting</th>
            <th>Data Export</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Mask Unblinded Content</td>
            <td><ul>
            <li>Both global and localized forms are generated with the global Product Placeholder Name (if it exists) or <code>PRIVACY</code> (if it does not exist).</li>
            <li><p>Product child records are not populated.</p> <p>Dosage export depends on your Admin's configuration. For more information, see <a href="/en/lr/01225/#dosage-masking-for-study-products">Dosage Masking for Study Products</a>.</p></li>
            </ul></td>
        </tr>
        <tr>
            <td>Blank</td>
            <td><ul>
            <li>Global forms are generated with the Product (Reported) name from the global Case.</li>
            <li>Localized forms are generated with the Product (Reported) name from the localized Case.</li>
            <li>Product child records are populated.</li>
            </ul></td>
        </tr>
    </tbody>
</table>

For general information on masking _Study_ content, see <a href="/en/lr/01225/#study-content-protection">Study Content Protection</a>.

### Distributions

When a _Reporting Family_ is set up to generate _Distributions_ for any _Case_ linked to a specified _Study_, the reporting rule engine generates _Distributions_ for blinded and unblinded _Products_. If a study _Case_ includes unblinded _Products_ with blinded and open-label _Products_, the unblinded and open-label _Products_ are eligible for reporting. If there are no unblinded _Products_, both blinded and open-label _Products_ are eligible for reporting.

When a _Reporting Family_ is set up to generate _Distributions_ for any _Case_ linked to a specified _Product_, the reporting rule engine generates _Distributions_ for unblinded _Products_ only, not for blinded _Products_.

## How Unblinding Works with Aggregate Reports

The following sections outline how the Clinical Trials: Isolate Blinded Product Information feature impacts masking on aggregate reports.

### Blinding Type

When generating primary _Case Products_, _Case Assessments_, _Case Assessment Result Causality_, Vault references the _Blinding Type_ field.

For unmasked documents, Vault prioritizes information based on _Blinding Type_ as follows:

1. _Unblinded_
2. _Blinded_
3. _Open_

For masked documents, Vault prioritizes information based on _Blinding Type_ as follows:

1. _Blinded_
2. _Open_

Regardless of document masking, if the _Blinding Type_ field is blank, Vault maps data as described in <a href="/en/lr/01128/">Generate Masked Aggregate Tabulations (CIOMS II, PBRER, and DSUR)</a>.

### DSUR and PBRER: Cumulative Tabulation of Serious Adverse Events From Clinical Trials

This section describes how Vault maps information to the _Blinded_ column of Cumulative Tabulation of Serious Adverse Events From Clinical Trials for DSURs and PBRERs when using blinded and unblinded records. For information about how Vault maps the remaining Cumulative Tabulation information, see the relevant sections in <a href="/en/lr/01280/#cumulative-tabulation-of-serious-adverse-events-from-clinical-trials">DSUR Aggregate Reports</a> and <a href="/en/lr/01282/#cumulative-tabulation-of-serious-adverse-events-from-clinical-trials">PBRER Aggregate Reports</a>.

<table>
    <thead>
        <tr>
            <th>Masked Reports</th>
            <th>Unmasked Reports</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><p>The total number of adverse events with suspect blinded products.</p>
            <p><strong>DSUR</strong></p>
            <p><code>COUNT IF<br>
            Case_version__v.study__v.blinded__v == Yes<br>OR<br>
            case_version__v.case_product__v.primary__v == Yes<a href="#omit-primary-product"><sup>1</sup></a><br>
            AND<br> 
            case_version__v.case_product__v.study_product__v == Blank OR case_product__v.blinding_type__v == Blinded<br>
            AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v</code></p>
            <p><strong>PBRER</strong></p>
            <p><code>COUNT IF<br>
            Case_version__v.study__v.blinded__v == Yes<br>OR<br>
            case_version__v.case_product__v.primary__v == Yes<a href="#omit-primary-product"><sup>1</sup></a><br>
            AND case_version__v.case_product__v.study_product__v == Blank OR case_product__v.blinding_type__v == Blinded<br>
            AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v</code></p></td>
            <td><p>The total number of adverse events with suspect unblinded products.</p>
            <p><strong>DSUR</strong></p>
            <p><code>COUNT IF<br>
            case_version__v.case_product__v.primary__v == Yes<a href="#omit-primary-product"><sup>1</sup></a><br>
            AND case_version__v.case_product__v.study_product__v == Blank OR case_product__v.blinding_type__v == Blinded<br>
            AND case_product__v.drug_role__v CONTAINS dsur__v.drug_roles_to_include__v</code></p>
            <p><strong>PBRER</strong></p>
            <p><code>COUNT IF<br>
            case_version__v.case_product__v.primary__v == Yes<a href="#omit-primary-product"><sup>1</sup></a><br>
            AND case_version__v.case_product__v.study_product__v == Blank OR case_product__v.blinding_type__v == Blinded<br>AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v</code></p></td>
        </tr>
    </tbody>
    <tfoot>
        <tr>
            <td colspan="2">
                <a id="omit-primary-product"></a>
                1. If the <a href="/en/lr/01381/">DSUR and PBRER Investigational Product Causality</a> feature is enabled in your Vault, <code>case_version__v.case_product__v.primary__v == Yes</code> is omitted.
            </td>
        </tr>
    </tfoot>
</table>

### DSUR: Interval Line Listings of Serious Adverse Reactions and List of Subjects Who Died During the Reporting Period

When generating Interval Line Listings of Serious Adverse Reactions and List of Subjects Who Died During the Reporting Period tables, Vault populates the _Suspect Drug_ column as follows:

<table>
    <thead>
        <tr>
            <th>Masked Reports</th>
            <th>Unmasked Reports</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><p>The name of the primary Case Product in the blinded record.</p>
            <p>First row (Primary Case Product):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v = Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>  
            {case_version__v.case_product__v.study_product_v = Blank<br>
            OR<br> 
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE<br> 
            case_version__v.case_product__v.product_name__v where primary__v = Yes</code></p>
            <p>Subsequent rows (non-Primary Case Products):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v != Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            {case_version_v.case_productv.study_product_v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE<br> 
            case_version__v.case_product__v.product_name__v where primary__v != Yes</code></p></td>
            <td><p>The name of the primary Case Product in the unblinded record.</p>
            <p>First row (Primary Case Product):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v = Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            {case_version__v.case_product__v.study_product__v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE<br> 
            case_version_v.case_product__v.product_name__v where primary__v = Yes</code></p>
            <p>Subsequent rows (non-Primary Case Products):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v != Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            {case_version__v.case_product__v.study_product__v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE case_version_v.case_productv.product_name_v where primary__v != Yes</code></p></td>
        </tr>
    </tbody>
</table>

When generating List of Subjects Who Died During the Reporting Period tables, Vault populates the _Daily Dose Route Formulation_ column as follows:

<table>
    <thead>
        <tr>
            <th>Masked Reports</th>
            <th>Unmasked Reports</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><p>The value is "Blinded".</p>
            <p>First row (Primary Case Product):</p>
            <p><code>IF<br>
            (case_product__v.primary__v = Yes)<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            (case_version__v.case_product__v.study_product__v = Blank)<br>
            THEN "Blinded"</code></p>
            <p>Subsequent rows (non-Primary Case Products):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v != Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br> 
            case_version__v.case_product__v.study_product__v = Blank]<br>
            THEN "Blinded"</code></p></td>
            <td><p>Values are mapped from the <strong>Case Product > Case Product Dosage</strong> as follows:</p>
            <p>First row (Primary Case Product):</p>
            <p><code>IF<br>
            (case_product__v.primary__v = Yes)<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            {case_version__v.case_product__v.study_product__v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE display:<br>
            case_product__v.case_product_dosage__v.dose_number__v<br>
            AND<br>
            dose_unit__v, case_product__v.case_product_dosage__v.frequency_number__v<br>
            AND<br>
            frequency_unit__v</code></p>
            <p>Subsequent rows (non-Primary Case Products):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v != Yes<br>
            AND<br> 
            case_version__v.case_product__v.product_type__v = Study Product<br>
            AND<br>
            {case_version__v.case_product__v.study_product__v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE display:<br>
            case_product__v.case_product_dosage__v.dose_number__v<br>
            AND<br>
            dose_unit__v, case_product__v.case_product_dosage__v.frequency_number__v<br>
            AND<br>
            frequency_unit__v</code></p>
            <p>If there are multiple Dosages under the primary Case Product, values from each <strong>Dosage</strong> record are displayed in a line-separated list.</p></td>
        </tr>
    </tbody>
</table>

### PADER

When generating <a href="/en/lr/01281/">PADER</a> documents, Vault references the _Blinding Type_ field to populate the following data:

* _Case Products_
* _Case Assessments_
* _Case Assessment Results_
* _Case Assessment Expectedness_

Vault determines the primary _Case Product_ as follows:

* Where blinded and unblinded records exist, Vault maps the primary _Case Product_ from the blinded record.
* Where only blinded records exist, Vault maps the primary _Case Product_ from that record.
* Where only unblinded or open-label records exist, Vault maps the primary _Case Product_ from that record.

### PSUR Summary Tabulation of Serious Unlisted Adverse Drug Reactions

When generating <a href="/en/lr/01283/#summary-tabulation-serious-unlisted">PSUR Summary Tabulation of Serious Unlisted Adverse Drug Reactions</a> tables, Vault references the _Blinding Type_ field to populate the following data:

* _Case Products_
* _Case Assessments_
* _Case Assessment Results_

Vault determines the primary _Case Product_ as follows:

* Where blinded and unblinded records exist, Vault maps the primary _Case Product_ from the blinded record.
* Where only blinded records exist, Vault maps the primary _Case Product_ from that record.
* Where only unblinded or open-label records exist, Vault maps the primary _Case Product_ from that record.

### CIOMS II Interval Line Listing of Adverse Drug Reactions

When generating <a href="/en/lr/01279/#cioms-ii-line-listing">CIOMS II Interval Line Listing of Adverse Drug Reactions</a> tables, Vault references the _Blinding Type_ field to populate data. When generating Interval Line Listing of Adverse Drug Reactions, Vault populates the _Suspect Drug_ column as follows:

<table>
    <thead>
        <tr>
            <th>Masked Reports</th>
            <th>Unmasked Reports</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><p>The name of the primary Case Product in the blinded record.</p>
            <p>First row (Primary Case Product):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v = Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>  
            {case_version__v.case_product__v.study_product_v = Blank<br>
            OR<br> 
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE <br>
            case_version__v.case_product__v.product_name__v where primary__v = Yes</code></p>
            <p>Subsequent rows (non-Primary Case Products):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v != Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            {case_version_v.case_productv.study_product_v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE<br> 
            case_version__v.case_product__v.product_name__v where primary__v != Yes</code></p>
            </td>
            <td><p>The name of the primary Case Product in the unblinded record.</p>
            <p>First row (Primary Case Product):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v = Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            {case_version__v.case_product__v.study_product__v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE<br> 
            case_version_v.case_product__v.product_name__v where primary__v = Yes</code></p>
            <p>Subsequent rows (non-Primary Case Products):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v != Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            {case_version__v.case_product__v.study_product__v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE<br> 
            case_version_v.case_productv.product_name_v where primary__v != Yes</code></p></td>
        </tr>
    </tbody>
</table>

When generating Interval Line Listing of Adverse Drug Reactions tables, Vault populates the _Daily Dose Route Formulation_ column as follows:

<table>
    <thead>
        <tr>
            <th>Masked Reports</th>
            <th>Unmasked Reports</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><p>The value is "Blinded".</p>
            <p>First row (Primary Case Product):</p>
            <p><code>IF<br>
            (case_product__v.primary__v = Yes)<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            (case_version__v.case_product__v.study_product__v = Blank)<br>
            THEN "Blinded"</code></p>
            <p>Subsequent rows (non-Primary Case Products):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v != Yes<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br> 
            case_version__v.case_product__v.study_product__v = Blank]<br>
            THEN "Blinded"</code></p></td>
            <td><p>Values are mapped from the <strong>Case Product > Case Product Dosage</strong> as follows:</p>
            <p>First row (Primary Case Product):</p>
            <p><code>IF<br>
            (case_product__v.primary__v = Yes)<br>
            AND<br> 
            case_version__v.case_product__v. product_type__v = Study Product<br>
            AND<br>
            {case_version__v.case_product__v.study_product__v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE display:<br>
            case_product__v.case_product_dosage__v.dose_number__v<br>
            AND<br>
            dose_unit__v, case_product__v.case_product_dosage__v.frequency_number__v<br>
            AND<br>
            frequency_unit__v</code></p>
            <p>Subsequent rows (non-Primary Case Products):</p>
            <p><code>IF<br> 
            [case_version__v.case_product__v.primary__v != Yes<br>
            AND<br> 
            case_version__v.case_product__v.product_type__v = Study Product<br>
            AND<br>
            {case_version__v.case_product__v.study_product__v = Blank<br>
            OR<br>
            case_product__v.blinding_type__v = Blinded}]<br>
            THEN "Blinded"<br>
            ELSE display:<br>
            case_product__v.case_product_dosage__v.dose_number__v<br>
            AND<br>
            dose_unit__v, case_product__v.case_product_dosage__v.frequency_number__v<br>
            AND<br>
            frequency_unit__v</code></p>
            <p>If there are multiple Dosages under the primary Case Product, values from each <strong>Dosage</strong> record are displayed in a line-separated list.</p></td>
        </tr>
    </tbody>
</table>

[1]: #switch-view
[2]: #cascade-delete
[3]: #overview
[5]: #expect-evals
[6]: #unblind-sp
[7]: #type-reference