Bulk Recode MedDRA-Coded Terms on Cases

Learn how to bulk recode non-current MedDRA-coded terms on Cases following active MedDRA dictionary version updates.

About MedDRA Bulk Recode Cases

When new MedDRA dictionary versions are activated, you can use the MedDRA Bulk Recode tool to update non-current MedDRA-coded terms on Cases. When upgrading MedDRA to the latest version, Vault automaticlly recodes MedDRA-coded terms with hierarchy changes.

MedDRA Bulk Recode offers the following capabilities for Business Admins:

Specify the 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 Case’s audit trail and summary report

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:

Object	Field
Case Product > Indication	Indication (LLT)
Case Adverse Event	Event (LLT)
Case Diagnosis	Name (MedDRA)
Case Cause of Death	Cause of Death (LLT)
Case Medical History & Concurrent Conditions	Condition/Procedure (LLT)
Case Drug History	Indication (LLT) Reaction (LLT)
Case Test Result	Test Name (LLT)

Note: Reported Terms are not affected by recoding.

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 lifecycle state 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.

Note: Bulk recoding is applied to Cases locked either manually or by strict case locking.

Recode Approved and Closed Cases

Vault identifies Cases in Approved and Closed states for the preview file differently depending on the Dictionary Bulk Action Scope value you specify in the Dictionary Bulk Action record:

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:

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

Procedure Overview

At a high level, MedDRA bulk recoding involves the following steps:

Create a Dictionary Bulk Action record to specify the recode settings.
Prepare and upload a mapping file of replacement terms and codes.
Preview the bulk recode.
Run the bulk recode.
Download the MedDRA Bulk Recode Summary Report.

Prerequisites

You must be a Business Admin with access to the Dictionaries library to bulk recode non-current MedDRA-coded terms.
Ensure your Vault has the necessary configuration to enable this feature. To recode all closed Case versions, the Dictionary Bulk Action Scope field must exist on the Dictionary Bulk Action object layout.

Create a Dictionary Bulk Action Record

Dictionary Bulk Action records enable you to specify recode settings, upload a MedDRA code mapping file, preview the bulk recode, and run the bulk recode. To create a record:

Go to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
In the Dictionary Bulk Actions section, select Create.
Complete the fields in the Details section.
Select Save.

Dictionary Bulk Action Fields

Field	Description
Name	Enter a name for the action, such as "Bulk Recode to MedDRA version [number]".
Organization	Select the Organization for which you want to complete the recode.
Replacement MedDRA version	Select the MedDRA version with the updated terms and codes.
Report Type	Optionally, select a type for the update. Leave this field blank to update Cases from all types.
Case State	Select the states you want to recode.
Study Type	If the Report Type field value is Study, you can select a type for the recode.
Study	If Study Type is populated, you can select a study for the recode.
Dictionary Bulk Action Scope	Select the version scope of this record: Latest Case Version: Recode the latest version of the Cases. All Case Versions: Recode the latest versions of the Cases and all prior versions in terminal lifecycle states that include a recoded MedDRA term. If this field is not available to populate, Vault recodes the latest versions.
Bulk Action Status	This field is updated by Vault when actions are run on the record. Statuses may be updated as follows: Preview Generated: When Vault completes the Preview Bulk Recode action. Bulk Action Initiated: When Vault starts the Run Bulk Recode action. Bulk Action Completed: When Vault completes the Run Bulk Recode action.

Prepare and Upload a Mapping File of Replacement Terms and Codes

To begin MedDRA bulk recoding of non-current terms, you must first upload a mapping file. The file must list each MedDRA LLT code and term that is being replaced, the replacement MedDRA code, and the MedDRA version in which the 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

Note: Mapping file columns cannot include commas. If a comma is included in any value, it is read as a separate item.

Mapping CSV Format

The following table describes the columns supported in the mapping.csv file:

Column	Description
Coded LLT	Each row must specify a MedDRA LLT code that is being replaced. Vault uses this code to search for Cases impacted by the MedDRA update.
Coded LLT Term	Each row must specify the MedDRA LLT term that is being replaced. The term must correspond to the code in the Coded LLT column.
Replacement LLT Code	Each row must specify the LLT Code that will replace the code in the Coded LLT column. 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: LLT Code PT Code
Replacement Version	Each row must include the version number of the MedDRA Dictionary with the replacement LLT codes. Note: A `mapping.csv` file can include one (1) replacement version number. The MedDRA Dictionary version must exist in your Vault’s Central MedDRA Dictionary.

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

Go to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
In the Dictionary Bulk Actions section, select a Bulk Dictionary Action record.
In the Attachments section, select Upload and then upload the mapping.csv file.

Result

When you run the Preview Bulk Recode action, the mapping.csv file is used for mapping non-current MedDRA codes to replacement codes.

Note: You cannot delete files after you upload them as attachments to Bulk Dictionary Action records. To replace an attached file, upload a new version with the same filename.

Preview Bulk Recode

Use the Preview Bulk Recode action to generate a report detailing the Cases that will be impacted by the MedDRA Bulk Recode. Vault can generate this report for up to 20,000 Cases per file, based on unique Case IDs. The Cases are filtered based on the recode settings you defined in the Dictionary Bulk Action record, such as Report Type and Case State.

To run the action:

Go to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
In the Dictionary Bulk Actions section, select a Bulk Dictionary Action record.
In the All Actions menu, select Preview Bulk Recode.

Result

Vault generates the report based on the mapping.csv file. Vault sends emails and notifications when the report is ready. The preview.csv can be downloaded directly from the email or from the Attachments section of the Bulk Dictionary Action record.

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, perform the following steps:

Open a new Excel file.
Perform the following actions depending on your operating system:
- Mac OS: Go to File > Import.
- Windows: Go to Data > From Text/CSV.
Select CSV file and then Import.
In your folder, select the downloaded preview.csv file and then select Get Data.
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).
Under Delimiters, deselect Tab, and then select Comma.
Perform the following actions depending on your operating system:
- Mac OS: Select Finish.
- Windows: Select Load.
If prompted to select where to import the data, select Existing sheet, and then select OK.

Result

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

Note: If there are multiple versions of an open Case, 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 Bulk Dictionary Action record.

Preview CSV Format

The following table describes the columns supported in the preview.csv file, which must be in the listed order:

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

Run Bulk Recode

MedDRA Bulk Recoding can be run using the existing preview.csv file in the Attachments section of the Dictionary Bulk Action record. Alternatively, the action can be run on another CSV file that is uploaded to that section. The file must be formatted to match the preview.csv file format, with the columns in the same listed order. The file can include up to 20,000 Cases, based on unique Case IDs.

To run the action:

Go to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
In the Dictionary Bulk Actions section, select a Bulk Dictionary Action record.
In the All Actions menu, select Run Bulk Recode.
On the Confirmation page, select a CSV from the file picklist, and then select Start Recode.

Note: Once you start the Run Bulk Recode action, it cannot be cancelled. You cannot run another recode until the first action completes.

Result

Vault initiates the recoding and the Bulk Action Status field updates to Bulk Action Initiated. Vault sends emails and notifications when the recoding is complete. At that time, the Bulk Action Status field updates to Bulk Action Completed, and the MedDRA Replacement Version field is updated with the version number of the MedDRA Dictionary in the file used for the recode action. You can download the summary report to review changes.

Download the MedDRA Bulk Recode Summary Report

When the bulk recoding completes, a downloadable summary report is generated detailing each impacted Case and the action taken. Access the report in Business Admin > Objects > Dictionaries > MedDRA Dictionary > Bulk Dictionary Action > Attachments. To download the file, select Download on the Log-(datetime).csv.

Summary Report Details

The following table describes the columns in the Log-(datetime).csv file:

Column Name	Description
Case	The Case number and name. This field includes a hyperlink to the Case.
Case ID	The Case identifier.
WWUID	The worldwide unique case identification (WWUID) number.
Object	The Case object with the MedDRA code that Vault recoded.
Record ID	The Vault ID for the impacted field.
Field	The Case field with the MedDRA code that Vault recoded.
Coded LLT	The original MedDRA LLT code on the Case.
Coded LLT Term	The original MedDRA LLT term on the Case.
Replacement LLT Code	The updated MedDRA LLT Code.
Replacement Version	The version number of the MedDRA Dictionary with the replacement LLT code.
Action Taken	Indicates if Vault created and recoded a Follow-up Case or if no action was taken.
Message	If applicable, identifies errors on the file used for the recoding.