# Generate a Regulatory Report

Vault maps _Case_ data to generate Individual Case Safety Reports (ICSRs) that are compliant, maintain _Case_ versions, and support multiple submission and distribution destinations. You can generate regulatory reports automatically as part of the _Transmission_ workflow or manually. To assist with review and assessment, you can also preview _Cases_ in regulatory report formats. Generated files appear in the _Library_ and are versioned during regeneration. For E2B reports in XML format, you can <a href="/en/lr/773988/">generate readable renditions</a> for document review.

### Transmissions for Clinical Trial Study Cases {#transmission-ct-cases}

When generating _Transmissions_, Vault generates reports using the _Case Assessment Expectedness_ record with a _Based On_ setting that matches the _Agency's_ setting. For more information, see <a href="/en/lr/822874/#date-based">Expectedness Evaluations for Clinical Trial Study Cases</a>.

## Supported ICSR Report Formats

Vault supports generating the following ICSR formats:

* **PDF:**
   * <a href="/en/lr/01222/">CIOMS I</a>: Generates the CIOMS I form
   * <a href="/en/lr/933063/">CIOMS I (Chinese)</a>: Generates a localized version of the CIOMS I form for submission to the National Health Commission (NHC) in China
   * <a href="/en/lr/872182/">EU MIR</a>: Generates the European Commission's Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD), Version 7.3.1
   * <a href="/en/lr/802644/">FDA 3500A</a>: Generates the FDA MedWatch 3500A form
   * <a href="/en/lr/827489/">PMDA MHLW Paper Form</a>: Generates the standard PMDA MHLW Paper Form forms based on the _PMDA Reporting Category_ on the _Local Reporting Details_ record of the Japan _Localized Case_
   * <a href="/en/lr/1005170/">PMDA postmarket medical device and regenerative medicine forms</a>:
      * PMDA Form 8: Generates the standard PMDA form for medical device malfunction and infectious disease case reports
      * PMDA Form 10: Generates the standard PMDA form for medical device research reports and investigation reports on measures taken in foreign countries
      * PMDA Form 13: Generates the standard PMDA form for postmarketing clinical studies of drugs
      * PMDA Form 14: Generates the standard PMDA form for clinical trials of medical devices

* **XML**:
    * **E2B(R3) XML:**
      * <a href="/en/lr/700007/">EMA E2B(R3)</a>: Generates an E2B(R3) file for electronic submissions to the European Medicines Agency (EMA) and the UK Medicines & Healthcare products Regulatory Agency (MHRA) gateway
      * <a href="/en/lr/725757/">FDA FAERS E2B(R3)</a>: Generates an E2B(R3) file for electronic submissions to the U.S. Food and Drug Administration (FDA) gateway
      * <a href="/en/lr/700006/">FDA VAERS E2B(R3)</a>: Generates an E2B(R3) file for vaccine-related electronic submissions to the U.S. Food and Drug Administration (FDA) VAERS gateway
      * <a href="/en/lr/700005/">ICH E2B(R3)</a>: Generates an E2B(R3) file compliant with the ICH common standard guidelines
      * <a href="/en/lr/782789/">MFDS E2B(R3)</a>: Generates an E2B(R3) file for electronic submissions to the Republic of Korea's Ministry of Food and Drug Safety (MFDS) gateway
      * <a href="/en/lr/823290/">NMPA E2B(R3)</a>: Generates an E2B(R3) file for electronic submissions to the China National Medical Products Administration (NMPA) gateway
      * <a href="/en/lr/700008/">PMDA E2B(R3)</a>: Generates an E2B(R3) file for electronic submissions to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) gateway
      * <a href="/en/lr/871674/">Vigiflow E2B(R3)</a>: Generates an E2B(R3) file for electronic submissions to the VigiFlow Industry eReporting adverse event management system
    * **E2B(R2) XML:**
      * <a href="/en/lr/756509/">EU Convention E2B(R2)</a>: Generates an E2B(R2) file compliant with EU convention regional guidelines required for agencies such as Swissmedic and the Therapeutic Goods Administration (TGA) of Australia
      * <a href="/en/lr/700010/">FDA E2B(R2)</a>: Generates an E2B(R2) file for electronic submissions to the U.S. Food and Drug Administration (FDA) gateway
      * <a href="/en/lr/700011/">HC E2B(R2)</a>: Generates an E2B(R2) file for electronic submissions to Health Canada (HC) gateway
      * <a href="/en/lr/700009/">ICH E2B(R2)</a>: Generates an E2B(R2) file compliant with the ICH common standard guidelines
    * <a href="/en/lr/872182/">EU MIR XML</a>: Generates the European Commission's Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD), Version 7.3.1
    * <a href="/en/lr/980119/">MHRA MIR XML</a>: Generates the European Commission's Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD), Version 7.2.1
    * <a href="/en/lr/936141/">FDA eMDR</a>: Generates the FDA electronic Medical Device Reporting (eMDR) XML
    * <a href="/en/lr/1005170/">PMDA postmarket medical device and regenerative medicine forms</a>:
      * PMDA Form 8: Generates the standard PMDA form for medical device malfunction and infectious disease case reports
      * PMDA Form 10: Generates the standard PMDA form for medical device research reports and investigation reports on measures taken in foreign countries
      * PMDA Form 13: Generates the standard PMDA form for postmarketing clinical studies of drugs
      * PMDA Form 14: Generates the standard PMDA form for clinical trials of medical devices

The links in the above list provide information on how Vault maps _Case_ data to generate reports in each of these formats. For more information on which report formats to generate for different regulatory agencies, see the report formats detailed on <a href="/en/lr/01245/">Standard Agency ICSR Submissions</a>.

## Automatic Generation of Reports for Transmissions

When a **Submission** record to a regulatory agency is created, Vault generates a regulatory report in the appropriate format, determined by the associated Transmission Profile.

When a **Distribution** record for a Partner Distribution Family or Reporting Obligation is created, Vault generates a regulatory report in the format specified on the **Distribution** record or associated Transmission Profile.

## Manually Generate a Submittable Report

You can generate any supported report format from a **Submission** or **Distribution** record using the **Generate Transmission Document(s)** user action.



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      <p><strong>Note</strong>: You cannot generate Transmission documents for <a href="/en/lr/01217/">Imported Cases</a>. The <strong>Generate Transmission Document(s)</strong> user action is visible for these Case types but the action does not generate a document. If you must generate a report, you can convert the Imported Case to a Case or Follow-up Case.</p>
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1. Go to the **Submission** or **Distribution** record.
2. Check that the report type in the **Transmission Document Type** field is the report that you want to generate.
3. To change the report type, select **Edit**, and then choose a different report in the **Transmission Document Type** field.
4. Expand the **All Actions** menu, and then select **Generate Transmission Document(s)**.

**Result**

Vault generates the Case Report document and adds a link to the document in the **File** field. If you do not see the file, refresh the page.

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      <p><strong>Note</strong>: If the Transmission document name exceeds 100 characters (the maximum length), the system automatically truncates it to 100 characters so that the Transmission document can generate successfully.</p>
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### PMDA MHLW Paper Form Requirements

To generate a _Transmission_ using a <a href="/en/lr/827489/">PMDA MHLW Paper Form</a> report type, a _Localized Case_ must include:

* _Japanese (Japan)_ in the _Localization_ field
* A value in the _PMDA Reporting Category_ field of the _Local Reporting Details_ record

## Generate a Report Preview from the Case

By default, users assigned the Data Entry, Reviewer, or Medical Reviewer role can generate reports from the Case page. However, your Admin may have configured your Vault differently.

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      <p><strong>Note</strong>: Reports generated from the Case page are intended to be used as previews and are not intended for Submissions. Generate reports from the <strong>Submission</strong> or <strong>Distribution</strong> record for a final version.</p>
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1. Go to the Case for which you want to generate a regulatory report preview.
2. Expand the **All Actions** menu, and then select the format you want to generate. The options available depend on your Admin's configuration. The following options are available by default in most Vaults:
   * **Generate Preview: CIOMS I**: Generates a CIOMS I Suspect Adverse Reaction Report.
   * **Generate Preview: E2B(R3)**: Generates an ICH E2B(R3) file.
   * **Generate Preview: MedWatch (3500A)**: Generates an FDA MedWatch 3500A form.
Vault generates the report and attaches it to the Case under **Documents**.
3. To view the report, expand **Documents**, and then select the name of the report. The **Classification** column identifies the report type.

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      <p><strong>Note</strong>: Your Admin can configure actions to generate forms in other E2B formats.</p>
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### <a id="blind-protection-on-regulatory-report-previews"></a>Blind-Protection on Report Previews

For blinded Study Cases, people without privileges to view unblinded data can generate regulatory report previews with all unblinded data masked or removed from the generated file.



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      <p><strong>Note</strong>: Study Product dosage is unblinded on report previews if dosage blinding has not been enabled by your Admin. <a href="/en/lr/01225/#dosage-masking">Dosage Masking for Study Products</a> provides more information.</p>
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See the following table for details on which regulatory report previews are generated based on blinding setup on Studies, Cases, and Study Arms:

<table>
   <thead>
      <tr>
         <th>Study Blinding Setup</th>
         <th>Case Blind Protection Setup</th>
         <th>Study Arm Setup</th>
         <th>Regulatory Report Previews Generated</th>
      </tr>
   </thead>
   <tbody>
      <tr>
         <td>Blinded</td>
         <td>Not blinded</td>
         <td>Blinded</td>
         <td>Masked only</td>
      </tr>
      <tr>
         <td>Blinded</td>
         <td>Not blinded</td>
         <td>Unarmed</td>
         <td>Masked only</td>
      </tr>
      <tr>
         <td>Blinded</td>
         <td>Not blinded</td>
         <td>Open</td>
         <td>Unmasked only</td>
      </tr>
      <tr>
         <td>Blinded</td>
         <td>Blinded</td>
         <td>N/A</td>
         <td>Masked and unmasked</td>
      </tr>
      <tr>
         <td>Not blinded</td>
         <td>N/A</td>
         <td>N/A</td>
         <td>Unmasked only</td>
      </tr>
   </tbody>
</table>

## E2B Document Attachments and Literature References

Learn how Vault <a href="/en/lr/826501/">attaches documents to E2B transmissions</a>.

## Case Access Groups

When <a href="/en/lr/01304/">configured by your Admin</a>, Vault populates the _Case Access Group_ field in the _Case Information_ section on the <a href="/en/lr/9753/">Doc Info pane</a> of generated documents. This value is based on the value inherited from the associated _Inbox Item_. You cannot modify this field value.