# Bulk Unblind Isolated Blinded Product Information

For Vaults configured to isolate blinded clinical trial information, you can unblind all _Cases_ under a completed _Study_ at once.

## About Bulk Unblind Isolated Blinded Product Information

When a blinded clinical trial for a study without study arms ends, you can unblind all _Cases_ at once as part of the end-of-study reconciliation. When you unblind _Cases_ in bulk, Vault removes blind protection for previously unblinded _Cases_ and populates _Study Product_ information for blinded closed clinical trial _Cases_. Depending on your Admin's configuration of <a href="/en/gr/01294/">suspect products</a>, Vault unblinds _Study Products_ with a _Drug Role_ of _Suspect_, _Interacting_, and _Drug Not Administered_. 

Vault preserves all _Case_ processing information by generating separate blinded and unblinded records for all global and localized records. Vault [updates the applicable _Study_ record][1] and [creates follow-up _Cases_][2] for closed _Cases_ that were not unblinded before the bulk unblind process. Vault records updates in the applicable audit log. Vault does not modify in-progress _Cases_ as part of unblinding.

This feature is available for Vaults configured to <a href="/en/gr/691317/">isolate blinded clinical trial information</a>. For Vaults without this configuration, see <a href="/en/gr/01181/">Bulk Unblind a Study</a> for information on how to unblind all study _Cases_ at once.

### Procedure Overview

To unblind all _Cases_ under a completed _Study_ at once:

1. Prepare [CSV files][5] for:
 * Study participants
 * Treatment group and blinded product placeholders
2. Complete [bulk unblinding][6]
3. Review the [summary report][7]

## Prerequisites

To use this feature:

* Your Admin must have enabled 
  * <a href="/en/gr/691318/">Clinical Trials: Isolate Blinded Product Information</a>  
  * <a href="/en/gr/01362/">Bulk Unblind</a>
  * <a href="/en/gr/774560/">Bulk Unblind Studies with Isolate Blinded Product Information</a>
* You must have Business Admin permissions and access to the _Study_ being reconciled.
* The _Study_ must not have <a href="/en/gr/01216/#studies-without-study-arms">_Study Arms_</a>.

## <a id="study-updates"></a>Study Updates

After bulk unblinding all blinded closed clinical trial _Cases_, Vault updates the source _Study_:

* Sets the _Blinded_ field to _No_.
* Sets the lifecycle state to _End of Study Reconciliation_.
* Adds a bulk unblind [summary report][7] to the _Attachment_ section.

## <a id="study-updates"></a>Follow-Up Case Creation

After running bulk unblinding, Vault creates a follow-up version of [all closed _Cases_ that were not previously unblinded][3]. For each blinded record on the _Case_, Vault copies the values and creates a separate unblinded record, setting the _Blinding Type_ to _Unblinded_. Each unblinded record references its associated blinded record. For more information about these dual records, see <a href="/en/gr/691317/">Isolate Blinded Clinical Trial Information</a>. 

Created follow-up _Cases_ are in the <a href="/en/gr/01171/#unblinding">_End of Study Unblinding_ state</a>. Vault updates information on these _Cases_ as follows:

* Vault appends text entered in the _Narrative Text_ field on the _Bulk Unblinding_ page to the _Narrative_ document.
* Vault maps text entered in the _Unblinding Reason_ field on the _Bulk Unblinding_ page to the _Unblinded Reason_ field on the _Case_.
* When the _Randomization Number_ field on the _Case_ is blank, Vault maps the [_Randomization Number_][4] from the CSV file. If needed, Vault truncates the value to 59 characters and appends `…`.
* Vault updates the _New Info Date_ and _Unblinded Date_ fields to the date of bulk unblinding, based on the initiating user's timezone.
* Vault sets the _Unblinded By_ field on the _Case_ to _Sponsor_.
* If the _Study Type_ field is blank, Vault maps the _Study Type_ value from the associated _Study_.
* Vault evaluates the latest information to update the _Case Expectedness_, _Listedness (Core)_, and _Relatedness_ fields.

Vault moves previous _Case_ versions to the _Superseded_ state and does not update their data.

### Product Information on Unblinded Records

Vault populates unblinded information on blinded _Case Product_ records as follows:

* For _Case Products_ with _Study Product Placeholders_ for clinical trial _Study Products_ with any _Study Product Role_ except _Standard of Care_, Vault maps the _Study Product_ data:
  * Vault maps the _Name_ of the _Study Product_ to the _Product (Coded)_ field.
  * If the _Product (Reported)_ field is blank or populated with the blinded name, Vault also maps the _Name_ of the _Study Product_ to this field.
* If you choose to add dosage information during bulk unblinding, Vault maps _Dosage_ information from the unblinded _Study Product_ record to the _Dosages_ section of the _Case Product_.
* If you choose to add indication information during bulk unblinding, Vault maps _Indication_ information from the _Study_ to the _Indications_ section of the _Case Product_.
  * For _Indication_ only, Vault maps this information to the blinded record as well.

Vault moves blinded _Case Product_ records to the _Unblinded_ state and sets the _Blinded_ field to _No_.

### Case Assessments on Unblinded Records

Vault populates unblinded information on blinded _Case Assessment_ and related records as follows:

* Vault generates _Case Assessment Expectedness_ records for each unblinded _Study Product_. Vault does not generate _Case Assessment Expectedness_ records for blinded _Study Products_ unless your Admin has configured <a href="/en/gr/774366/">Datasheet Expectedness for Blinded Study Products</a>.
* Vault generates _Case Assessment Result_ records for each source type, copying values from the blinded record.
* If the _Blinding Type_ field is blank on a _Study Product_ record, Vault generates both blinded and unblinded records.

### Localized Cases

If the initial _Case_ has a related domestic _Localized Case_, Vault creates a follow-up domestic _Localized Case_ that includes all of the new records from the generated global follow-up _Case_. For unblinded products with PMDA registrations, Vault also generates _Case Product Registration_, _Localized Case Assessment_, and _Localized Case Assessment Result_ records. If dosage and indication details were mapped to the global _Case_, Vault also populates them on the domestic _Localized Case_.

If the initial _Case_ has related foreign _Localized Cases_, Vault creates follow-up foreign _Localized Cases_. However, Vault maps information from the related global follow-up _Case_ upon _Transmission_ generation.

## <a id="prepare-csv-files"></a>Prepare the CSV Files

Before you begin unblinding, you must upload two (2) CSV files to the _Bulk Unblinding_ page:

* A list of each patient in the study and the treatment group they were in.
* A list of the treatment groups and blinded names for the _Study Products_.

When preparing the files, consider that:

* The file type must be CSV.
* A file can contain up to 20,000 rows.
* Column headers must have the required names and order.

### <a id="study-participants"></a>Prepare a CSV File of Study Participants

Each combination of either `investigational_mrn` and `treatment_group` or `patient_initials` and `treatment_group` must be unique. Use the following column header names and order:

<table>
    <thead>
        <tr>
            <th>Column</th>
            <th>Character Limit</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><code>patient_initials</code></td>
            <td>60</td>
            <td><p>Each row must specify at least one (1) patient identifier from a <em>Case</em>. This can be <code>patient_initials</code> or <code>investigational_mrn</code>. When both values are included and do not match, Vault considers <code>investigational_mrn</code>.</p>
            <p>This value matches to the <em>Patient Initials</em> field on the <em>Case</em> object.</p></td>
        </tr>
        <tr>
            <td><code>investigational_mrn</code></td>
            <td>20</td>
            <td><p>Each row must specify at least one (1) patient identifier from a <em>Case</em>. This can be <code>patient_initials</code> or <code>investigational_mrn</code>. When both values are included and do not match, Vault considers <code>investigational_mrn</code>.</p>
            <p>This value matches to the <em>MRN - Investigation</em> field on the <em>Case</em> object.</p></td>
        </tr>
        <tr>
            <td><code>study</code></td>
            <td>-</td>
            <td><p>(Required) Identifies the <em>Study</em> for which <em>Cases</em> will be unblinded. The value must match either the name or number of a <em>Study</em> on a <em>Case</em>.</p>
            <p>This value matches to either of the following fields:</p>
                <ul>
                    <li><em>Case > Study > Name</em></li>
                    <li><em>Case > Study Number</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><code>treatment_group</code></td>
            <td>-</td>
            <td><p>(Required) Identifies the treatment group the patient was assigned.</p></td>
        </tr>
        <tr>
            <td><a id="random-number"></a><code>randomization_number</code></td>
            <td>200</td>
            <td><p>(Optional) Identifies the patient's randomization number from the clinical trial randomization system.</p>
            <p>Vault maps this value to the <em>Randomization Number</em> field of the <a href="#follow-up-case-creation">follow-up <em>Case</em></a> created after unblinding.</p></td>
        </tr>
    </tbody>
</table>

#### CSV Sample

We recommend reviewing this sample CSV file:

```
patient_initials,investigational_mrn,study,treatment_group,randomization_number 
AR,pt001,STU-004,Investigational,jfgoubas7823nf982
MM,pt002,STU-004,Investigational,fdggf3212fsdf
SK,pt003,STU-004,Placebo,f32c6665ggdg
FL,pt004,STU-004,Active Comparator,324dsgasd235
EW,pt005,STU-004,Active Comparator,fhhybg57674
SKI,pt006,STU-004,Placebo,mnut564
AL,pt007,STU-004,Investigational,khuyjh754d43
RP,pt008,STU-004,Investigational,75hgf65jhgg
SS,pt009,STU-004,Placebo,hrfg5453
```

### <a id="treatment-group"></a>Prepare a Treatment Group and Blinded Product Placeholders CSV File

Each row must be unique. Use the following column header names and order:

<table>
    <thead>
        <tr>
            <th>Column</th>
            <th>Character Limit</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><code>treatment_group</code></td>
            <td>-</td>
            <td><p>(Required) Identifies the treatment group the patient was assigned.</p></td>
        </tr>
        <tr>
            <td><code>study_product</code></td>
            <td>-</td>
            <td><p>(Required) Identifies the <em>Study Product</em> being unblinded. The value must match either the name or number of a <em>Study Product</em> in the <em>Study</em>.</p>
            <p>This value matches to either of the following fields:</p>
                <ul>
                    <li><em>Case > Study > Study Product > Name</em></li>
                    <li><em>Case > Study > Study Product > Product</em></li>
                </ul>
            </td>
        </tr>
        <tr>
            <td><code>study_product_placeholder</code></td>
            <td>128</td>
            <td><p>(Required) Identifies the <em>Study Product Placeholder</em> for the <em>Study Product</em> being unblinded. The value must match a <em>Study Product Placeholder</em> in the <em>Study</em>.</p>
            <p>This value matches to the <em>Case > Study > Study Product Placeholder > Name</em> field.</p></td>
        </tr>
    </tbody>
</table>

#### CSV Sample

We recommend reviewing this sample CSV file:

```
treatment_group,study_product,study_product_placeholder 
Investigational,cholecap,Investigational vs. Placebo
Placebo,wonderdrug,Investigational vs. Comparator
```

## <a id="bulk-unblind-cases"></a>Bulk Unblind Cases

Initiate bulk unblinding from a _Study_ record. You cannot bulk unblind _Cases_ across different _Studies_. For information on unblinding an individual _Case_ for SUSAR reporting, see <a href="/en/gr/01176/">Manage Case Blinding</a>.

1. Navigate to the applicable _Study_ record.
2. From the **All Actions** menu, select **Launch Bulk Actions**.
3. In the _Upload List of Study Participants_ section of the _Bulk Unblinding_ page, select **Upload** to upload the [CSV file][9] of study participants.
4. In the _Upload List of Treatment Group and Blinded Product Placeholders_ section, select **Upload** to upload the [CSV file][10] of the treatment group and blinded product placeholders.
5. (Optional) In the _Unblinding Options_ section, apply updates to the [follow-up _Case_][2] created after unblinding:
   1. In the **Narrative Text** field, enter up to 2,000 characters to append to the _Narrative_ document.
   2. In the **Unblinding Reason** field, enter up to 250 characters to populate the _Unblinded Reason_ field on the _Case_.
   3. In the **Dosage Options** field, select whether to add _Dosage_ information from the unblinded _Study Product_ to the _Dosages_ section of the _Case Product_.
   4. In the **Indication Options** field, select whether to add _Indication_ information from the _Study_ to the _Indications_ section of the _Case Product_.
6. Select **Preview Bulk Unblind**. Vault populates the right-hand panel with:
 * The number of _Cases_ that will be unblinded
 * A [Summary of Changes][8]
 * Source File Information
7. To apply the details from the bulk unblind preview, select **Run Bulk Unblind**.

**Result**

When bulk unblinding completes, Vault generates a [summary report][7] of all changes. You can navigate to other pages during report generation. Vault displays a notification when all applicable _Cases_ are unblinded.

### <a id="summary-of-changes"></a>Summary of Changes

_Cases_ are categorized by color based on how Vault updates them after bulk unblinding:

<table>
            <thead>
                <tr>
                    <th>Category</th>
                    <th>Color</th>
                    <th>Description</th>
                </tr>
            </thead>
            <tbody>
                <tr>
                    <td>Previously Unblinded Cases</td>
                    <td>Green</td>
                    <td>Unblinded <em>Cases</em> identified by:
                        <ul>
                            <li>The <em>Case Blinded</em> field is set to <em>No</em>.</li>
                            <li>The <em>Blind Protection</em> field is set to <em>On</em>.</li>
                        </ul>
                        <p>These Cases can be in <a href="/en/gr/01171/">any lifecycle state</a>, including a <em>Closed</em> state.</p>
                        <p>After running bulk unblinding, Vault removes blind protection from these <em>Cases</em> and all related documents. If any blinded records do not already have unblinded equivalents, Vault generates the missing unblinded records.</p>
                    </td>
                </tr>
                <tr>
                    <td><a id="closed-cases"></a>Closed Cases to Unblind</td>        
                    <td>Blue</td>
                    <td>Closed blinded <em>Cases</em> identified by:
                        <ul>
                            <li>The <em>Case Blinded</em>  field is set to <em>Yes</em> or blank.</li>
                            <li>The <em>Case</em> is in the <em>Approved</em> or <em>Closed</em> <a href="/en/gr/01171/">lifecycle state</a>.</li>
                        </ul>
                        <p>After running bulk unblinding, Vault creates a new <em>Case</em> version with <a href="#follow-up-case-creation">follow-up information</a> added, along with domestic and foreign <em>Localized Cases</em> when applicable.</p>
                    </td>
                </tr>
                <tr>
                    <td>Inflight Cases</td>       
                    <td>Purple</td>
                    <td>In-flight <em>Cases</em> identified by:
                        <ul>
                            <li>The <em>Case Blinded</em>  field is set to <em>Yes</em> or blank.</li>
                            <li>The <em>Case</em> is in any active <a href="/en/gr/01171/">lifecycle state</a> (such as <em>Data Entry</em>, <em>QC</em>, or <em>Medical Review</em>).</li>
                        </ul>
                        <p>Vault does not update these Cases as a result of bulk unblinding.</p>
                    </td>
                </tr>
                <tr>
                    <td>Cases Without Matching Patient</td>       
                    <td>Red</td>
                    <td><p><em>Cases</em> associated with the <em>Study</em> that did not match a patient in the <a href="#study-participants">CSV file</a>.</p>
                        <p>Vault does not update these Cases as a result of bulk unblinding.</p></td>
                </tr>
            </tbody>
</table>

## <a id="summary-report"></a>Summary Report

Vault generates a summary report of changes from bulk unblinding. When the report is ready, the Vault notification links to the report, which is also attached to the associated _Study_. The summary report is an XLSX file with the following tabs:

<table>
    <thead>
        <tr>
            <th>Tab</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Input</td>
            <td>The options selected on the <em>Bulk Unblinding</em> screen, the user who ran the action, the date and time the action ran, and the name of the source CSV files</td>
        </tr>
        <tr>
            <td>Summary</td>
            <td>The number of Cases in each <a href="#summary-of-changes">category</a>.</td>
        </tr>
        <tr>
            <td>Activity Log</td>
            <td>A detailed log of each <em>Case</em> evaluated and changed during bulk unblinding, including the following columns:
                <ul>
                    <li>case: The name of the <em>Case</em></li>
                    <li>wwuid: The worldwide unique case identification (WWUID) number on the <em>Case</em></li>
                    <li>action_taken: The action Vault took on the Case, such as:
                        <ul>
                            <li>Remove Blind Protection</li>
                            <li>Create follow-up and unblind</li>
                            <li>Blind Protection was off. No change was made</li>
                        </ul>
                    </li>
                    <li>message: Warning or error messages, if applicable</li>
                    <li>patient_id: The patient identifier used to match the <em>Case</em> to the <a href="#study-participants">CSV file</a></li>
                    <li>fields_updated: A list of Vault fields modified by the bulk unblind action</li>
                </ul>
            </td>
        </tr>
    </tbody>
</table>

[1]: #study-updates
[2]: #follow-up-case-creation
[3]: #closed-cases
[4]: #random-number
[5]: #prepare-csv-files
[6]: #bulk-unblind-cases
[7]: #summary-report
[8]: #summary-of-changes
[9]: #study-participants
[10]: #treatment-group