# Generate Masked Safety Reports

Vault can selectively mask sensitive information on Individual Case Safety Reports (ICSRs). When you generate a _Submission_ or _Distribution_, you can choose to protect confidential or blinded data, such as all of a patient's identifiable and health information, only identifiable information, or unblinded study data. In addition, your Admin can configure masking settings on <a href="/en/lr/01254/">_Partner Distribution Lists_</a>. This enables generating masked distributions for partner organizations, while continuing to generate unblinded ICSRs for agency submissions.

Vault generates masked reports for the following types of _Transmissions_:

* **Distributions**: When configured by your Admin, Vault generates <a href="/en/lr/01264/#vault-created-masked-distributions">masked _Distributions_</a>. Otherwise, you can edit the masking fields on <a href="/en/lr/1022564/">manual _Distributions_</a>. Vault generates masked _Distributions_ when the following conditions are met:
  * The _Study_ belongs to a _Partner Distribution_ type of <a href="/en/lr/01179/">_Reporting Family_</a> with a _Distribution Rule_ that references a <a href="/en/lr/01252/">_Safety Rule Set_</a> with a [_Study Content Protection_][5] value of _Yes_.
  * The _Study Content Protection_ value of the _Distribution_ is _Yes_.
* **Submissions**: Based on your Admin's <a href="/en/lr/01250/#mask-pii">configuration</a>, Vault generates _Submissions_ with masking for all _Cases_ or only foreign _Cases_. You can also edit the masking fields on <a href="/en/lr/1022564/">manual _Submissions_</a>.

The following _Transmission_ fields control safety report masking:

* [_Patient Content Protection_][6]
* [_Exceptions to Patient Content Protection_][3]
* [_Study Content Protection_][7]

## Prerequisites

To use the features on this page, your Admin must configure:

* <a href="/en/lr/01391/">Masked Content Distributions</a>
* <a href="/en/lr/01422/">Configurable Field Masking</a>
* <a href="/en/lr/758369/">Configurable PII and E2B Masking for NullFlavor Fields</a>

In addition to the masking field settings for _Submissions_ and _Distributions_, your Admin can enable your Vault to:

* <a href="/en/lr/740208/#mask-dosage">Mask dosage for _Study Products_</a>
* <a href="/en/lr/740208/#mask-reporter">Mask the reporter for postmarket non-literature _Cases_</a>
* <a href="/en/lr/740208/#display-unmasked">Unmask</a> open-label _Products_ within blinded _Studies_ on blinded CIOMS I and FDA 3500A forms

## Patient Content Protection {#pcp}

When generating _Transmissions_, use the _Patient Content Protection_ field to configure masking for personally identifiable information (PII). The options are:

* _Mask PII_: Masks the fields in the [table below][4].
* _Mask PII (EU Guidance)_: Masks the same fields as the _Mask PII_ option, with some [exceptions][8].
* _Mask E2B (Includes PII)_: Masks the same fields as the _Mask PII_ option, with some [additions][9].

You can configure masking exceptions for Patient Content Protection (PCP) using the [_Exceptions to Patient Content Protection_][3] field.

### Mask Personally Identifiable Information (PII) {#PII}

Vault masks the following fields when you select _Mask PII_ while configuring a <a href="/en/lr/01256/#distribution-rules">_Partner Distribution Rule_</a>:

<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>: When the <em>Date of Birth</em> field is masked, Age and Age Group information is transmitted during E2B transmission.</p>
    </div>
  </div>
</div>



<table>
   <thead>
      <tr>
         <th>Object</th>
         <th>Field</th>
         <th>FDA 3500A/FDA eMDR/CIOMS I/EU MIR/MHRA MIR Mask Indicator</th>
         <th>E2B(R3) Mask Indicator</th>
         <th>E2B(R2) Mask Indicator</th>
      </tr>
   </thead>
   <tbody>
      <tr>
         <td rowspan="13"><em>Case Contact (<code>case_contact__v</code>)</em></td>
         <td><em>Title</em> (<code>title_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>First Name</em> (<code>firstname_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>Middle Name</em> (<code>middlename_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>Last Name</em> (<code>lastname_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>Organization</em> (<code>organization_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>Department</em> (<code>department_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>Street</em> (<code>street_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>City</em> (<code>city_value__v</code>)</td>
         <td>N/A</td>
         <td>N/A</td>
         <td><code>PRIVACY</code><sup>1</sup></td>
      </tr>
      <tr>
         <td><em>State / Province</em> (<code>state_province_value__v</code>)</td>
         <td>N/A</td>
         <td>N/A</td>
         <td><code>PRIVACY</code><sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Postal Code</em> (<code>postalcode_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>Telephone</em> (<code>telephone_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Fax</em> (<code>fax__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Email Address</em> (<code>email_address__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td rowspan="17"><em>Case</em> (<code>case_version__v</code>)</td>
         <td><em>Reporter First Name</em> (<code>reporter_first_name__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>Reporter Last Name</em> (<code>reporter_last_name__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>Patient Initials</em> (<code>patient_id_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>Sex</em> (<code>gender_value__v</code>)</td>
         <td>Left blank</td>
         <td><code>MSK</code><sup>3</sup></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Race</em> (<code>race__v</code>)</td>
         <td>Left blank<sup>4</sup></td>
         <td>N/A</td>
         <td>N/A</td>
      </tr>
      <tr>
         <td><em>Ethnicity</em> (<code>ethnicity__v</code>)</td>
         <td>Left blank<sup>4</sup></td>
         <td>N/A</td>
         <td>N/A</td>
      </tr>
      <tr>
         <td><em>MRN - GP</em> (<code>mrn_gp_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>MRN - Specialist</em> (<code>mrn_specialist_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>MRN - Hospital</em> (<code>mrn_hospital_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>MRN - Investigation</em> (<code>mrn_investigation_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Date of Birth</em> (<code>dob_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Date of Birth (normalized)</em> (<code>dob_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Last Menstrual</em> (<code>last_menstrual_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code><sup>3</sup></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Last Menstrual (normalized)</em> (<code>last_menstrual_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Medical History Text</em> (<code>medical_history_text__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code><sup>3</sup></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Date of Death</em> (<code>dod_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code><sup>3</sup></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Date of Death (normalized)</em> (<code>dod_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td rowspan="2"><em>Case Product</em> (<code>case_product__v</code>)</td>
         <td><em>Date Implanted</em> (<code>date_implanted__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
      <tr>
         <td><em>Date Explanted</em> (<code>date_explanted__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>2</sup></td>
      </tr>
   </tbody>
   <tfoot>
      <tr>
         <td colspan="5">1. Masked on ICH E2B(R2) and FDA E2B(R2) reports only.
         </td>
      </tr>
      <tr>
         <td colspan="5">2. This is either not a valid element or nullFlavor for E2B(R2). If this is a valid element, the element will not be transmitted in place of being masked.
         </td>
      </tr>
      <tr>
         <td colspan="5">3. When exporting an EMA E2B(R3) with a transmission destination of EMA or Swissmedic, this field is not masked. If the field contains a manually entered MSK value, then the field is omitted from the transmission.
         </td>
      </tr>
      <tr>
         <td colspan="5">4. These regional data elements appear only on FDA MedWatch 3500A and FDA eMDR reports.
         </td>
      </tr>
   </tfoot>
</table>

### Mask PII (EU Guidance) {#eu-guidance}

When the _Patient Content Protection_ on a _Submission_ is _Mask PII (EU Guidance)_, Vault masks the [same fields as for the _Mask PII_ setting][4] with the following exceptions:

* Vault does not mask the following _Case Version_ fields:
    * _Patient Initials / ID_
    * _Sex_
    * _MRN - Investigation_
    * _Date of Birth_
    * _Date of Birth (normalized)_
    * _Last Menstrual_
    * _Last Menstrual (normalized)_
    * _Medical History Text_
    * _Date of Death_
    * _Date of Death (normalized)_
* Vault masks the _Patient Initials / ID_ on the _Parent Information_ record when generating E2B(R3) and E2B(R2) files. Vault masks by populating `MSK` on E2B(R3) files and `PRIVACY` on E2B(R2) files.
* For the _Sender (User)_ on the _Submission_, Vault exports the following fields as blank:
    * _Title_
    * _First Name_
    * _Middle Name_
    * _Last Name_
    * _Street_
    * _City_
    * _State / Province_
    * _Zip / Postal Code_
    * _Country Code_
    * _Telephone_
    * _Fax_

### Exceptions to Patient Content Protection {#exceptions}

When using PCP, you can select PII fields to leave unmasked. You can configure masking exceptions for the following fields using the _Exceptions to Patient Content Protection_ drop-down:

<table>
   <thead>
      <tr>
         <th>Exception</th>
         <th>Unmasked Field</th>
         <th>Object</th>
      </tr>
   </thead>
   <tbody>
      <tr>
         <td>Blank Fields</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Parent Sex</td>
         <td><em>Sex</em> (<code>gender_value__v</code>)<sup>1,2</sup></td>
         <td><em>Case</em> (<code>case_version__v</code>) (Parent)</td>
      </tr>
      <tr>
         <td>Patient Sex</td>
         <td><em>Sex</em> (<code>gender_value__v</code>)<sup>1</sup></td>
         <td><em>Case</em> (<code>case_version__v</code>)</td>
      </tr>
      <tr>
         <td>Reporter Country</td>
         <td><em>Country</em> (<code>country_value__v</code>)</td>
         <td><em>Case Contact</em>  (<code>case_contact__v</code>) (Reporter)</td>
      </tr>
      <tr>
         <td>Null Flavors</td>
         <td>All fields configured with <a href="/en/lr/01219/"><em>Reasons Omitted</em></a> options.</td>
         <td>-</td>
      </tr>
   </tbody>
   <tfoot>
      <tr>
         <td colspan="3">1. When exporting an EMA E2B(R3) with a transmission destination of EMA or Swissmedic, this field is not masked. If the field contains a manually entered MSK value, then the field is omitted from the transmission.
         </td>
      </tr>
      <tr>
         <td colspan="3">2. As MHRA MIR files do not include parent fields, masking does not apply to that format.
         </td>
      </tr>
   </tfoot>
</table>

### E2B Mask (Includes Personally Identifiable Information) {#e2b-mask}

Vault masks all of the [PII fields listed above][4], as well as the fields in the following table when you select _E2B Mask_ while configuring a _Partner Distribution Rule_.

<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 FDA VAERS E2B(R3) exports, as <code class="language-plaintext highlighter-rouge">MSK</code> is not a valid nullFlavor for these E2B data elements, Vault does not mask:</p>

<ul>
  <li>FDA.D.13 - Pregnant at Time of Vaccination</li>
  <li>FDA.C.2.r.2.3 - Reporter’s Street Address - LINE 2</li>
</ul>
    </div>
  </div>
</div>



<table>
   <thead>
      <tr>
         <th>Object</th>
         <th>Field</th>
         <th>FDA 3500A/FDA eMDR/CIOMS I/EU MIR/MHRA MIR Mask Indicator</th>
         <th>E2B(R3) Mask Indicator</th>
         <th>E2B(R2) Mask Indicator</th>
      </tr>
   </thead>
   <tbody>
      <tr>
         <td rowspan="4"><em>Case Contact</em> (<code>case_contact__v</code>)</td>
         <td><em>County</em> (<code>county_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Country</em> (<code>country_value__v</code>)</td>
         <td><code>*****</code><br><em>Form checkbox is blank (G.3)</em></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>City</em> (<code>city_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td><em>State / Province</em> (<code>state_province_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td><code>PRIVACY</code></td>
      </tr>
      <tr>
         <td rowspan="7"><em>Case</em> (<code>case_version__v</code>)</td>
         <td><em>Event Onset</em> (<code>event_onset_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Event Onset (normalized)</em> (<code>event_onset_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Race</em> (<code>race__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Ethnicity</em> (<code>ethnicity__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Pregnant at Vaccination</em> (<code>pregnant_at_vaccination__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Product Generic Name</em> (<code>generic_name__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>MPID Version</em> (<code>mpid_version__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td rowspan="5"><em>Case Adverse Event</em> (<code>case_adverse_event__v</code>)</td>
         <td><em>Onset</em> (<code>onset_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Onset (normalized)</em> (<code>onset_normalized__v</code>) </td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Cessation</em> (<code>resolved_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Cessation (normalized)</em> (<code>resolved_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Duration</em><br><em>Duration (unit)</em> <br>(<code>duration_number__v)<br>(duration_unit__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td rowspan="4"><em>Case Drug History</em> (<code>case_drug_history__v</code>)</td>
         <td><em>Start Date</em> (<code>startdate_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Start Date Normalized</em> (<code>startdate_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>End Date</em> (<code>enddate_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>End Date Normalized</em> (<code>end_date_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td rowspan="5"><em>Case Medical History</em> (<code>case_medical_history__v</code>)</td>
         <td><em>Start Date</em> (<code>startdate_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Start Date Normalized</em> (<code>startdate_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Continuing</em> (<code>continuing_value__v</code>)</td>
         <td><code>*****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>End Date</em> (<code>enddate_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>End Date Normalized</em> (<code>enddate_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td rowspan="5"><em>Case Product Dosage</em> (<code>case_product_dosage__v</code>)</td>
         <td><em>First Administration</em> (<code>firstadmin_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>First Administration (normalized)</em> (<code>firstadmin_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Last Administration</em> (<code>lastadmin_idate__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Last Administration (normalized)</em> (<code>lastadmin_normalized__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
      <tr>
         <td><em>Duration (number)</em><br><em>Duration (unit)</em><br>(<code>duration_number__v)<br>(duration_unit__v</code>)</td>
         <td><code>**-***-****</code></td>
         <td><code>MSK</code></td>
         <td>Left blank<sup>1</sup></td>
      </tr>
   </tbody>
   <tfoot>
      <tr>
         <td colspan="5">1. This is either not a valid element or nullFlavor for E2B(R2). If this is a valid element, the element will not be transmitted in place of being masked.
         </td>
      </tr>
   </tfoot>
</table>

## Study Content Protection {#study-content-protection}

Use the _Study Content Protection_ field to configure masking for unblinded information on _Study Cases_.

<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>: Study Content Protection is not supported when generating PMDA E2B(R3) reports for the PMDA.</p>
    </div>
  </div>
</div>



### Mask Unblinded Content

Vault masks the fields in the table when you select _Mask Unblinded Content_ while configuring a _Partner Distribution Rule_. Consider the following when masking unblinded content:

* When you select _Mask Unblinded Content_ on a Spontaneous Case with Study Content Protection, the Case's Product information will remain unblinded on CIOMS I, FDA 3500A, EU MIR, and MHRA MIR forms.
* By default, Product Dosage information is unmasked. However, your Admin can enable <a href="/en/lr/01420/">Mask Dosage in Blinded Distributions</a> to apply with the _Mask Unblinded Content_ option.

<table>
    <thead>
        <tr>
            <th>Object</th>
            <th>Field</th>
            <th>FDA 3500A/FDA eMDR/CIOMS I/EU MIR/MHRA MIR Mask Indicator</th>
            <th>E2B(R2) and (R3) Mask Indicator</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td rowspan="22"><em>Case Product</em> (<code>case_product__v</code>)</td>
            <td><em>Product (Coded)</em> (<code>product_name_v</code>)</td>
            <td>Blinded name or <code>*****</code> if no blinded name</td>
            <td>Blinded name or <code>MSK</code> if no blinded name</td>
        </tr>
        <tr>
            <td><em>Product (Reported)</em> (<code>product_reported__v</code>)</td>
            <td>Blinded name or <code>*****</code> if no blinded name</td>
            <td>Blinded name or <code>MSK</code> if no blinded name</td>
        </tr>
        <tr>
            <td><em>MPID</em> (<code>mpid__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>MPID Version</em> (<code>mpid_version__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>PhPID</em> (<code>phpid__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>PhPID Version</em> (<code>phpid_version__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Registration Number</em> (<code>registration_number__v</code>)</td>
            <td>Left blank</td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Registration Country</em> (<code>registration_country__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Registration Holder/Applicant</em> (<code>registration_mah__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Organization</em> (<code>Organization__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Expiration Date</em> (<code>expiration_date__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Name</em> (<code>name__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Model Number</em> (<code>model_number__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Catalog Number</em> (<code>catalog_number__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Serial Number</em> (<code>serial_number__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Lot Number</em> (<code>lot_number__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Unique Identifier</em> (<code>unique_Identifier__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Reprocessed/Reused</em> (<code>reprocessed__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Reprocessor</em> (<code>reprocessor__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Additional Information</em> (<code>additional_information_coded__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Other Additional Information</em> (<code>additional_information_text__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Blinded</em> (<code>blinded__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Case Product Dosage</em> (<code>case_product_dosage__v</code>)</td>
            <td><em>Batch/Lot Number</em> (<code>batchlot_number__v</code>)</td>
            <td>Left blank</td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td rowspan="5"><em>Case Product Substance</em> (<code>case_product_substance__v</code>)</td>
            <td><em>Name (Reported)</em> (<code>name_reported__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>TermID Version</em> (<code>termid_version__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>TermID</em> (<code>termid__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Strength (Number)</em> (<code>strength_number__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Strength (Unit)</em> (<code>strength_unit__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>        <tr>
            <td rowspan="2"><em>Product</em> (<code>product__v</code>)</td>
            <td><em>Manufacturer</em> (<code>manufacturer__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
        <tr>
            <td><em>Generic Name</em> (<code>generic_name__v</code>)</td>
            <td><code>*****</code></td>
            <td>Left blank</td>
        </tr>
    </tbody>
</table>

## Dosage Masking for Study Products {#dosage-masking}

Vault does not mask product dosage in masked _Distributions_. However, Vault supports masking _Study Product_ dosage on E2B, CIOMS I, FDA MedWatch 3500A, and FDA eMDR reports. If <a href="/en/lr/740208/#mask-dosage">configured</a> by your Admin, _Study Product_ dosage masking applies to:

* Masked _Distributions_ where _Study Content Protection_ is _Mask Unblinded Content_
* Blinded report previews (manually generated from blinded study _Cases_)

### Masked Dosage Fields

If dosage masking is enabled, Vault masks the following dosage information:

* Dose
* Patient Route of Administration
    * Including Parent Route of Administration, when present, on CIOMS I forms
* Dose Frequency
<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>: Dose Frequency is not displayed if the <strong>Frequency</strong> field is blank when generating a report.</p>
    </div>
  </div>
</div>



### Dosage Masking by Format

Vault masks dosage by report type as follows:

* **CIOMS I**: Populates `*****` in Box 15 and 16
* **FDA MedWatch 3500A**: Populates `*****` in Box C3
* **FDA eMDR**: Populates `*****` in data element C.3
* **E2B(R3)**: Omits section G.k.4.r
* **E2B(R2)**: Omits the following data elements:
   * B.4.k.3
   * B.4.k.5
   * B.k.4.6
   * B.k.4.7
   * B.4.k.8
   * B.4.k.9
   * B.4.k.12
   * B.4.k.14
   * B.4.k.15

## Reporter Masking for Postmarket Non-Literature Cases {#reporter-masking-for-postmarket-non-literature-cases}

If <a href="/en/lr/740208/#mask-reporter">configured</a> by your Admin, Vault masks reporter information in all outbound _Submissions_ and _Distribution_ for postmarket non-literature _Cases_. The following conditions must be met to mask reporter fields for a _Case_:

* The Case **Report Type** must correspond to a postmarket, non-literature report type:
    * **_Postmarket_**: The Case must meet one of the following conditions to be considered "postmarket":
        1. _Non-Study Report Type_: The Case **Report Type** specifies a non-study report type. That is, the Report Type corresponds to a <a href="/en/lr/01195/#report-type">Controlled Vocabulary</a> of "Spontaneous" (E2B Code of `1`), "Other" (E2B Code of `3`), or "Not Available" (E2B Code of `4`).
        2. _Postmarket Study Case_: The Case **Report Type** corresponds to a Study <a href="/en/lr/01195/#report-type">Controlled Vocabulary</a> (E2B Code of `2`) and the Case **Study Type** corresponds to a <a href="/en/lr/01195/#study-type">Controlled Vocabulary</a> of "Individual Patient Use" (E2B Code of `2`) or "Other Study" (E2B Code of `3`).
    * **_Non-Literature_**: The Case **Report Type** field specifies a non-literature report type. That is, the option selected corresponds to a <a href="/en/lr/01195/#report-type">Report Type Controlled Vocabulary</a> with the **Literature** field set to "No" or unspecified.

### Masked Reporter Fields

Vault masks the following information for _Reporter_-type _Case Contacts_ when generating any report format:

* _Title_ (`title_value__v`)
* _First Name_ (`firstname_value__v`)
* _Middle Name_ (`middlename_value__v`)
* _Last Name_ (`lastname_value__v`)
* _Organization_ (`organization_value__v`)
* _Department_ (`department_value__v`)
* _Street_ (`street_value__v`)
* _Postal Code_ (`postalcode_value__v`)
* _Telephone_ (`telephone_value__v`)
* _Fax_ (`fax__v`)
* _Email Address_ (`email_address__v`)

If the _Patient Content Protection_ field specifies _E2B Mask_ on a _Transmission_, Vault also masks the reporter's _Country_ (`country_value__v`).

### Reporter Masking by Format

The following table outlines how reporter masking impacts different report types:

<table>
    <thead>
        <tr>
            <th>Report Type</th>
            <th>Reporter Masking</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><ul><li>CIOMS I</li>
                <li>FDA MedWatch 3500A</li>
                <li>FDA eMDR</li>
                <li>EU MIR</li>
                <li>MHRA MIR</li></ul></td>
            <td>Vault exports only the <em>Reporter Qualification</em> and <em>Reporter Country</em> fields. If these fields are blank, Vault transmits no reporter information.</td>
        </tr>
        <tr>
            <td>E2B(R3)</td>
            <td><p>Vault masks specified reporter fields with <code>MSK</code>. Vault does not transmit empty fields.</p>
            <p>In accordance with FDA guidance, for FDA VAERS E2B(R3) and FDA FAERS E2B(R3) reports, when the reporter's country is the United States, data elements in the C.2.r Primary Source(s) of Information section are unmasked even when the <em>Mask Reporter For PM Non-Literature Case</em> setting is enabled.</p></td>
        </tr>
        <tr>
            <td>E2B(R2)</td>
            <td>Specified reporter fields are masked with <code>PRIVACY</code>. Vault does not transmit empty fields.</td>
        </tr>
    </tbody>
</table>

[1]: #dosage-masking
[2]: #reporter-masking-for-postmarket-non-literature-cases
[3]: #exceptions
[4]: #PII
[5]: #study-content-protection
[6]: #pcp
[7]: #study-content-protection
[8]: #eu-guidance
[9]: #e2b-mask