# Bulk Recode MedDRA-Coded Terms

When new MedDRA dictionary versions are activated, you can use the MedDRA Bulk Recode tool to update non-current MedDRA-coded terms on _Cases_, _Product-Event Combinations_, _Datasheets_, _Watchlists_, and _MedDRA Queries_. The MedDRA Bulk Recode tool allows you to:
* Specify bulk recode settings
* Preview and validate MedDRA code changes before committing them
* Run bulk recoding in a single action
* See changes tracked in detail in the audit trail and summary report

When upgrading MedDRA to the latest version, Vault automatically recodes MedDRA-coded terms on _Cases_ with hierarchy changes.

## Prerequisites
To use this feature:
* You must be a Business Admin with access to the _Dictionaries_ library
* Your Admin must enable:
    * <a href="/en/gr/01343/">MedDRA Bulk Recode Cases</a>
    * <a href="/en/gr/1006554/">MedDRA Bulk Recode for Administrative Maintenance</a>

## Bulk Recode Cases {#bulk-recode-cases}
To bulk-recode MedDRA terms on _Cases_:
1. [Create a _Dictionary Bulk Action_][1] to specify the recode settings.
2. [Prepare and upload a mapping file of replacement terms and codes][2].
3. [Preview the bulk recode][3].
4. [Run the bulk recode][4].
5. Optional: [Download the MedDRA Bulk Recode summary report][5].

### How Vault Safety Bulk Recodes Cases
When Vault recodes MedDRA-coded terms, it also re-calculates _Expectedness_ and _Watchlists_ on the _Case_. Vault can bulk recode non-current MedDRA-coded terms on up to 20,000 _Cases_ at once. The _Case_ fields that may be recoded include the following:

<table>
    <thead>
        <tr>
            <th>Object</th>
            <th>Field</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Case Product > Indication</td>
            <td>Indication (LLT)</td>
        </tr>
        <tr>
            <td>Case Adverse Event</td>
            <td>Event (LLT)</td>
        </tr>
        <tr>
            <td>Case Diagnosis</td>
            <td>Name (MedDRA)</td>
        </tr>
        <tr>
            <td>Case Cause of Death</td>
            <td>Cause of Death (LLT)</td>
        </tr>
        <tr>
            <td>Case Medical History & Concurrent Conditions</td>
            <td>Condition/Procedure (LLT)</td>
        </tr>
        <tr>
            <td>Case Drug History</td>
            <td><ul><li>Indication (LLT)</li>
                <li>Reaction (LLT)</li>
            </ul></td>
        </tr>
        <tr>
            <td>Case Test Result</td>
            <td>Test Name (LLT)</td>
        </tr>
    </tbody>
</table>

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    <div class="alert-text">
      <p><strong>Note</strong>: Reported Terms are not affected by recoding.</p>
    </div>
  </div>
</div>



### Recode Open Cases

Bulk recoding of non-current MedDRA-coded terms on active open _Cases_ and Follow-up _Cases_ is completed on the same _Case_ version. Active _Cases_ are open _Cases_ in a <a href="/en/gr/01171/#case-states">lifecycle state</a> prior to any _Void_, _Submitted_, or _Completed_ state, such as _Data Entry_, _QC_, and _Medical Review_. When Vault updates a MedDRA-coded term on an open _Case_, the record's lifecycle state changes to _Recoded_.

<div class="note-border alert-info">
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      <p><strong>Note</strong>: Bulk recoding is applied to <em>Cases</em> locked either manually or by strict case locking.</p>
    </div>
  </div>
</div>



### Recode Approved and Closed Cases {#closed}

Vault identifies _Cases_ in _Approved_ and _Closed_ states for the preview file differently depending on the _Approved/Closed Case Bulk Action Scope_ value you specify in the [_Dictionary Bulk Action_][1]:
* **Latest Case Version**: Identifies MedDRA-coded terms on the latest _Case_ versions. If the _Dictionary Bulk Action Scope_ field is not available to populate, Vault identifies the latest _Case_ versions.
* **All Case Versions**: Identifies MedDRA-coded terms on all _Case_ versions and all prior versions in terminal lifecycle states that contain a MedDRA term you are recoding. 

Vault completes the following actions when recoding closed _Cases_:

1. **Identifies**: Vault searches through the applicable closed _Cases_ for terms identified to recode.
2. **Recodes**: Vault replaces the identified MedDRA-coded terms with the new MedDRA codes and terms.
3. **Generates Summary Report**: When recoding is complete, Vault generates a downloadable summary report detailing each impacted _Case_ and the action taken.

## Bulk Recode Product-Event Combinations, Datasheets, Watchlists, and MedDRA Queries {#bulk-recode-objects}
To bulk-recode MedDRA terms on <a href="/en/gr/896824/">_Product-Event Combinations_</a>, <a href="/en/gr/01198/">_Datasheets_</a>, <a href="/en/gr/01192/">_Watchlists_</a>, and <a href="/en/gr/01189/">_MedDRA Queries_</a>:
1. [Create a _Dictionary Bulk Action_][1] to specify the recode settings.
2. [Identify recode candidates][10].
3. [Preview the bulk recode][3].
4. [Run the bulk recode][4].
5. Optional: [Download the MedDRA Bulk Recode summary report][5].

## Create a Dictionary Bulk Action {#create-a-dictionary-bulk-action-record}
To create a _Dictionary Bulk Action_:
1. Navigate to **Business Admin > Objects > Dictionaries > MedDRA Dictionary**.
2. Expand the **Dictionary Bulk Actions** section, then select **Create**.
3. In the _Create Dictionary Bulk Action_ dialog, select an action type to define the scope of the recode, then select **Continue**:
    * **Case Bulk Recode Action**: Bulk-recode MedDRA terms on [_Cases_][8]
    * **Hierarchy Bulk Recode Action**: Bulk-recode MedDRA terms on [_Product-Event Combinations_, _Datasheets_, _Watchlists_, and _MedDRA Queries_][9]
4. Complete the applicable [fields][11], then select **Save**.
 
### Dictionary Bulk Action Fields {#dictionary-bulk-action-fields}
The following fields may be available:
<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Name</em></td>
            <td>Enter a name for the action.</td>
        </tr>
        <tr>
            <td><em>Dictionary</em></td>
            <td>Vault populates <em>MedDRA Dictionary</em>.</td>
        </tr>
        <tr>
            <td><em>Dictionary Bulk Action Type</em></td>
            <td>Vault populates the action type.</td>
        </tr>
        <tr>
            <td><em>Bulk Action Status</em></td>
            <td>Vault populates a status whenever an action is run on the record.</td>
        </tr>
        <tr>
            <td><em>Replacement MedDRA Version</em></td>
            <td>
                <p>When creating a <em>Case Bulk Recode Action</em>, select the MedDRA version with the updated terms and codes.</p>
                <p>When creating a <em>Hierarchy Bulk Recode Action</em>, Vault populates the <em>Latest Loaded MedDRA Version</em> value on the <em>MedDRA Dictionary</em>. This represents the active MedDRA version in your Vault at the time the <em>Dictionary Bulk Action</em> was created.</p>
                <p>Upon completing <a href="/en/gr/01183/#run-bulk-recode">bulk recode</a>, Vault populates the MedDRA version used to complete the recode.</p>
                 <div class="note-border alert-info">
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    <div class="alert-text">
      <p><strong>Note</strong>: To create a <em>Hierarchy Bulk Recode Action</em>, Vault requires this field to have a value. To populate this field, <a href="/en/gr/01187/#download">download the latest central MedDRA dictionary version</a>.</p>
    </div>
  </div>
</div>


            </td>
        </tr>
        <tr>
            <td><em>Approved/Closed Case Bulk Action Scope</em></td>
            <td>When creating a <em>Case Bulk Recode Action</em>, select a value to define <a href="/en/gr/01183/#closed">the <em>Case</em> versions Vault should consider for recoding</a>.</td>
        </tr>
        <tr>
            <td><em>Organization</em></td>
            <td>Select the <a href="/en/gr/01213/"><em>Organization</em></a> for which you want to complete the recode.</td>
        </tr>
        <tr>
            <td><em>Case State</em></td>
            <td>When creating a <em>Case Bulk Recode Action</em>, select the states you want to recode.</td>
        </tr>
        <tr>
            <td><em>Report Type</em></td>
            <td>Optional: When creating a <em>Case Bulk Recode Action</em>, select a type for the update. Leave this field blank to update <em>Cases</em> from all types.</td>
        </tr>
        <tr>
            <td><em>Study Type</em></td>
            <td>Optional: If the <em>Report Type</em> value is <em>Study</em>, select a study type for the recode.</td>
        </tr>
        <tr>
            <td><em>Study</em></td>
            <td>Optional: If <em>Study Type</em> is populated, select a <a href="/en/gr/01216/"><em>Study</em></a> for the recode.</td>
        </tr>
        <tr>
            <td><em>Hierarchy Level</em></td>
            <td>When creating a <em>Hierarchy Bulk Recode Action</em>, select the level of the MedDRA hierarchy you want to consider for recoding.</td>
        </tr>
        <tr>
            <td><em>Scope</em></td>
            <td>When creating a <em>Hierarchy Bulk Recode Action</em>, select the object you want to consider for recoding.</td>
        </tr>
    </tbody>
</table>

## Prepare and Upload a Mapping File of Replacement Terms and Codes {#prepare-upload-mapping-file}
To begin MedDRA bulk recoding of non-current terms for _Cases_, you must first upload a mapping file to define each MedDRA LLT code and term that is being replaced, the replacement MedDRA code, and the MedDRA version in which the replacement code is found.

See the following considerations when preparing the file:

* The file format must be CSV
* The file name must be `mapping.csv`
* The file must include between 1 and 20,000 rows.
* The column names must appear as shown below and in the following order:
  * Coded LLT
  * Coded LLT Term
  * Replacement LLT Code
  * Replacement Version

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      <p><strong>Note</strong>: Mapping file columns cannot include commas. If a comma is included in any value, it is read as a separate item.</p>
    </div>
  </div>
</div>



### Mapping CSV Format
The following table describes the columns supported in the `mapping.csv` file:

<table>
    <thead>
        <tr>
            <th>Column</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Coded LLT</td>
            <td>Each row must specify a MedDRA LLT code that is being replaced. Vault uses this code to search for <em>Cases</em> impacted by the MedDRA update.</td>
        </tr>
        <tr>
            <td>Coded LLT Term</td>
            <td>Each row must specify the MedDRA LLT term that is being replaced. The term must correspond to the code in the <em>Coded LLT</em> column.</td>
        </tr>
        <tr>
            <td>Replacement LLT Code</td>
            <td>Each row must specify the LLT Code that will replace the code in the Coded LLT column. <br><p>All Replacement LLT Codes must exist in the MedDRA Dictionary identified in the Replacement Version column of the file. A Replacement LLT Code is considered part of the MedDRA Dictionary if it is found in either of the following fields, based on priority:
                <ul><li><em>LLT Code</em></li>
                    <li><em>PT Code</em></li>
                </ul></p></td>
        </tr>
        <tr>
            <td>Replacement Version</td>
            <td>Each row must include the version number of the MedDRA Dictionary with the replacement LLT codes.
                <div class="note-border alert-info">
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      <p><strong>Note</strong>: A <code>mapping.csv</code> file can include one (1) replacement version number. The MedDRA Dictionary version must exist in your Vault’s Central MedDRA Dictionary.</p>
    </div>
  </div>
</div>

</td>
        </tr>
    </tbody>
</table>

### Mapping CSV Sample
See the following example `mapping.csv` file: 

```
Coded LLT,Coded LLT Term,Replacement LLT Code,Replacement Version
12345678,Rash,23456789,25.0
87654321,Pneumonia,98765432,25.0
22345678,Fever,33456789,25.0
77654321,Insomnia,58765432,25.0
32345678,Headache,43456789,25.0
67654321,Fatigue,78765432,25.0
```

### Upload the Mapping CSV File
To upload the mapping file:
1. Navigate to **Business Admin > Objects > Dictionaries > MedDRA Dictionary**.
2. In the _Dictionary Bulk Actions_ section, select a _Dictionary Bulk Action_.
3. In the **Attachments** section, select **Upload** and then upload the `mapping.csv` file.

When you run the [_Preview Bulk Recode_ action][3], Vault uses the `mapping.csv` file to map non-current MedDRA codes to replacement codes.

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      <p><strong>Note</strong>: You cannot delete files after you upload them as attachments to <em>Dictionary Bulk Actions</em>. To replace an attached file, upload a new version with the same filename.</p>
    </div>
  </div>
</div>



## Identify Recode Candidates {#identify-recode-candidates}
To identify the [_Product-Event Combinations_, _Datasheets_, _Watchlists_, or _MedDRA Queries_][9] available for recoding:
1. Navigate to **Business Admin > Objects > Dictionaries > MedDRA Dictionary**.
2. From the _Dictionary Bulk Actions_ section, select the relevant _Hierarchy Bulk Recode Action_ type of _Dictionary Bulk Action_.
3. From the **All Actions** menu, select **Identify Recode Candidates**.

Upon completion, Vault:
* Sends a notification to the user who ran the action.
* Compiles a list of all MedDRA terms on the object records defined by the _Dictionary Bulk Action_, provided the term is no longer current according to the <a href="/en/gr/01187/#download">latest loaded MedDRA version</a>.
* Generates a CSV file titled `recode_list.csv` containing all recode candidate object records and attaches it to the _Attachments_ section of the _MedDRA Dictionary_.

To download the recode list file, navigate to the _MedDRA Dictionary_, expand the _Attachments_ section, then on the file, select **All Actions > Download**.

## Preview Bulk Recode {#preview-bulk-recode}
To generate a report detailing the object records that will be impacted by the MedDRA Bulk Recode:

1. Navigate to **Business Admin > Objects > Dictionaries > MedDRA Dictionary**.
2. Expand the **Dictionary Bulk Actions** section, then select a _Dictionary Bulk Action_.
3. In the **All Actions** menu, select **Preview Bulk Recode**.

Vault generates a CSV file titled `preview.csv` based on the [`mapping.csv`][2] or [`recode_list.csv`][10] file, then sends emails and notifications when the report is ready. Download the `preview.csv` file directly from the email or from the _Attachments_ section of the _Dictionary Bulk Action_. 

### View the Preview CSV File
The `preview.csv` is best viewed in a text editor. When viewed in Microsoft Excel, an issue may occur with some unsupported characters because Excel does not automatically encode them as UTF-8. To view the preview file in Excel:

1. Open a new Excel file.
2. Perform the following actions depending on your operating system:
    * **Mac OS**: Go to **File > Import**.
    * **Windows**: Go to **Data > From Text/CSV**.
3. Select **CSV** file and then **Import**.
4. In your folder, select the downloaded `preview.csv` file and then select **Get Data**.
5. On the first page, configure the data as follows, and then select **Next**.
    * Select **Delimited**.
    * From the **File Origin** drop-down, select **Unicode (UTF-8)**.
6. Under **Delimiters**, deselect **Tab**, and then select **Comma**.
7. Perform the following actions depending on your operating system:
    * **Mac OS**: Select **Finish**.
    * **Windows**: Select **Load**.
8. If prompted to select where to import the data, select **Existing sheet**, and then select **OK**.

The unsupported characters on the preview file are now viewable in Excel.

<div class="note-border alert-info">
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      <p><strong>Note</strong>: If there are multiple versions of an open <em>Case</em>, both will be listed in the preview file. You can manually delete rows with Cases that you do not want to recode, and then import the revised file to the <em>Dictionary Bulk Action</em> record.</p>
    </div>
  </div>
</div>



### Preview CSV Format for Cases {#preview-csv-format}
The following table describes the columns supported in the `preview.csv` file for _Cases_, which must be in the listed order:

<table>
    <thead>
        <tr>
            <th>Column</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Case</td>
            <td>The <em>Case</em> number and name.</td>
        </tr>
        <tr>
            <td>Case ID</td>
            <td>The <em>Case</em> identifier.</td>
        </tr>
        <tr>
            <td>WWUID</td>
            <td>The worldwide unique case identification (WWUID) number for an external safety case.</td>
        </tr>
        <tr>
            <td>Object</td>
            <td>The <em>Case</em> object with the MedDRA code that will be recoded.</td>
        </tr>
        <tr>
            <td>Record ID</td>
            <td>The Vault <em>Record ID</em> for the impacted field.</td>
        </tr>
        <tr>
            <td>Field</td>
            <td>The <em>Case</em> field with the MedDRA code that will be recoded.</td>
        </tr>
        <tr>
            <td>Coded LLT</td>
            <td>The MedDRA LLT code that is currently in the identified <em>Case</em> field.</td>
        </tr>
        <tr>
            <td>Coded LLT Term</td>
            <td>The MedDRA LLT term that is currently in the identified <em>Case</em> field. </td>
        </tr>
        <tr>
            <td>Replacement LLT Code</td>
            <td>The MedDRA LLT Code that will replace the code in the Coded LLT column.</td>
        </tr>
        <tr>
            <td>Replacement Version</td>
            <td>The version number of the MedDRA Dictionary with the replacement LLT codes.</td>
        </tr>
    </tbody>
</table>

## Run Bulk Recode {#run-bulk-recode}
To bulk-recode MedDRA terms:
1. Navigate to **Business Admin > Objects > Dictionaries > MedDRA Dictionary**.
2. Expand the **Dictionary Bulk Actions** section, then select a _Dictionary Bulk Action_.
3. From the **All Actions** menu, select **Run Bulk Recode**.
4. On the _Confirmation_ page, select a [`preview.csv` file][3]<sup><a href="#custom-preview-csv">1</a></sup> from the file picklist, and then select **Start Recode**.

Vault initiates the recoding and updates the _Bulk Action Status_ to _Bulk Action Initiated_.

When the recoding is complete, Vault:
* Updates the MedDRA terms on the specified object records
* Adds an <a href="/en/gr/517/">audit trail</a> to each updated record to capture the recode event
* Updates the following fields on the _Dictionary Bulk Action_:
    * **Bulk Action Status**: Populates _Bulk Action Completed_
    * **Replacement MedDRA Version**: Populates the MedDRA version used to complete the updates
* Sends an email and a notification to the user who initiated the action
* Generates a [summary report][5] with an overview of the recode results

<a id="custom-preview-csv"></a>
 <div class="note-border alert-info">
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    <div class="alert-text">
      <p><strong>Note</strong>: 1. When bulk recoding <em>Cases</em>, you can use the <code class="language-plaintext highlighter-rouge">preview.csv</code> file generated by Vault, or you can upload your own CSV file to the <em>Attachments</em> section of the <em>Dictionary Bulk Action</em>, provided it is formatted to match the <code class="language-plaintext highlighter-rouge">preview.csv</code> file format, with the <a href="/en/gr/01183/#preview-csv-format">columns in the same listed order</a>. The <code class="language-plaintext highlighter-rouge">preview.csv</code> file can include up to 20,000 <em>Cases</em>, based on unique <em>Case IDs</em>.</p>
    </div>
  </div>
</div>



## Download the MedDRA Bulk Recode Summary Report {#download-summary-report}
Upon completing the bulk recode, Vault generates a downloadable summary report detailing each impacted object record and the action taken. To download the summary report:
1. Navigate to **Business Admin > Objects > Dictionaries > MedDRA Dictionary**. 
2. Expand the **Dictionary Bulk Actions** section and select a _Dictionary Bulk Action_.
3. From the _Dictionary Bulk Action_, expand the **Attachments** section and locate the relevant file. 
4. From the **All Actions** menu, select **Download**.

### Summary Report Details for Case Recoding
Upon recoding _Cases_, the summary report includes the following columns:
<table>
    <thead>
        <tr>
            <th>Column Name</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>Case</td>
            <td>The <em>Case</em> number and name. This field includes a hyperlink to the <em>Case</em>.</td>
        </tr>
        <tr>
            <td>Case ID</td>
            <td>The <em>Case</em> identifier.</td>
        </tr>
        <tr>
            <td>WWUID</td>
            <td>The worldwide unique case identification (WWUID) number.</td>
        </tr>
        <tr>
            <td>Object</td>
            <td>The <em>Case</em> with the MedDRA code that Vault recoded.</td>
        </tr>
        <tr>
            <td>Record ID</td>
            <td>The Vault ID for the impacted field.</td>
        </tr>
        <tr>
            <td>Field</td>
            <td>The <em>Case</em> field with the MedDRA code that Vault recoded.</td>
        </tr>
        <tr>
            <td>Coded LLT</td>
            <td>The original MedDRA LLT code on the <em>Case</em>.</td>
        </tr>
        <tr>
            <td>Coded LLT Term</td>
            <td>The original MedDRA LLT term on the <em>Case</em>.</td>
        </tr>
        <tr>
            <td>Replacement LLT Code</td>
            <td>The updated MedDRA LLT Code.</td>
        </tr>
        <tr>
            <td>Replacement Version</td>
            <td>The version number of the MedDRA Dictionary with the replacement LLT code.</td>
        </tr>
        <tr>
            <td>Action Taken</td>
            <td>Indicates if Vault created and recoded a Follow-up <em>Case</em> or if no action was taken.</td>
        </tr>
        <tr>
            <td>Message</td>
            <td>If applicable, identifies errors on the file used for the recoding.</td>
        </tr>
    </tbody>
</table>

### Summary Report Details for Product-Event Combination, Datasheet, Watchlist, and MedDRA Query Recoding
Upon recoding _Product-Event Combinations_, _Datasheets_, _Watchlists_, or _MedDRA Queries_, the summary report includes the following columns:

<table>
  <thead>
    <tr>
      <th>Column Name</th>
      <th>Description</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td>Object</td>
      <td>The object record with the MedDRA code that Vault recoded.</td>
    </tr>
    <tr>
      <td>Object Type</td>
      <td>The object type.</td>
    </tr>
    <tr>
      <td>Record ID</td>
      <td>The Vault ID for the impacted object record.</td>
    </tr>
    <tr>
      <td>Field</td>
      <td>The field with the MedDRA code that Vault recoded.</td>
    </tr>
    <tr>
      <td>Hierarchy</td>
      <td>The level of the MedDRA hierarchy that Vault recoded.</td>
    </tr>
    <tr>
      <td>Current MedDRA ID</td>
      <td>The original MedDRA ID on the object record.</td>
    </tr>
    <tr>
      <td>Current MedDRA Code</td>
      <td>The original MedDRA code on the object record.</td>
    </tr>
    <tr>
      <td>Current MedDRA Term</td>
      <td>The original MedDRA term on the object record.</td>
    </tr>
    <tr>
      <td>Replacement MedDRA ID</td>
      <td>The updated MedDRA ID.</td>
    </tr>
    <tr>
      <td>Replacement MedDRA Code</td>
      <td>The updated MedDRA code.</td>
    </tr>
    <tr>
      <td>Replacement MedDRA Term</td>
      <td>The updated MedDRA term.</td>
    </tr>
    <tr>
      <td>Replacement Version</td>
      <td>The version number of the MedDRA Dictionary with the replacement MedDRA code.</td>
    </tr>
    <tr>
      <td>Message</td>
      <td>If applicable, identifies errors on the file used for the recoding.</td>
    </tr>
  </tbody>
</table>

[1]: #create-a-dictionary-bulk-action-record
[2]: #prepare-upload-mapping-file
[3]: #preview-bulk-recode
[4]: #run-bulk-recode
[5]: #download-summary-report
[6]: #preview-csv-format
[7]: #closed
[8]: #bulk-recode-cases
[9]: #bulk-recode-objects
[10]: #identify-recode-candidates
[11]: #dictionary-bulk-action-fields