Bulk Recode MedDRA-Coded Terms on Cases

You can bulk recode the MedDRA-coded terms on Cases using the MedDRA Bulk Recode feature.

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About MedDRA Bulk Recode Cases

When new MedDRA Dictionary versions are released, you can use the MedDRA Bulk Recode tool to update the MedDRA-coded terms on Cases.

Available to Business Administrators, MedDRA Bulk Recode offers the following capabilities:

  • Preview and validate MedDRA code changes before committing them.
  • Run bulk recoding in a single action.
  • See changes tracked in detail in a Case audit trail and summary report.

For details on configuring your Vault for this feature, see Enable MedDRA Bulk Recode Cases.

How Vault Safety Bulk Recodes Cases

Vault Safety can bulk recode MedDRA-coded terms on up to 20,000 Cases at one time. 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 Active Cases

Bulk recoding of non-current MedDRA-coded terms on active Cases and Follow-Up Cases is completed in the same Case version. Active Cases are open Cases in a state prior to any Void, Submitted, or Completed state, such as Data Entry, QC, Medical Review. See more information on lifecycle states.

When MedDRA-coded terms are updated, Expectedness is re-evaluated on the Case. The Case Audit Trail tracks all system changes.

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

Recode Approved and Closed Cases

For Approved and Closed Cases with non-current MedDRA-coded terms, the system completes the following actions:

  • 1Creates a Follow-Up Case: The system creates a new version of the Case and imports all relevant information from the initial version. Original Cases in the Approved state remain in that state. Original Cases in the Closed state become Superseded. MedDRA-coded terms on the original Cases are not recoded.
  • 2Recoding: On the Follow-Up Cases, the MedDRA-coded terms are replaced with the new MedDRA codes and terms.
  • 3Updates State to Recoded: When the recoding is complete, the Follow-Up Case state becomes "Recoded".

    Note The system does not re-evaluate Expectedness or Watchlists during bulk recoding of Closed and Approved Cases. Follow your organization's established process to determine next steps, such as evaluating reporting obligations. Contact Veeva Support for assistance on configuring any required workflows.

  • 4Generates a Summary Report: When the recoding is complete, a downloadable summary report is generated detailing each impacted Case and the action taken.

Procedure Overview

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

  1. Create a Dictionary Bulk Action record.
  2. Prepare and upload a mapping file of replacement terms and codes.
  3. Preview the bulk recode.
  4. Run the bulk recode.
  5. Download the MedDRA Bulk Recode Summary Report

Audit Logging

When the bulk recoding runs, all changes are recorded in the applicable Case audit log as “System on behalf of {user}.”

Prerequisites

  • You must be a Business Administrator with access to the Dictionaries library to bulk recode MedDRA-coded terms.
  • Ensure your Vault has the necessary configuration to enable this feature.

Create a Dictionary Bulk Action Record

Dictionary Bulk Action records enable you to upload a MedDRA code mapping file, preview the bulk recode, and run the bulk recode.

  1. Go to Business Admin > Dictionaries > MedDRA Dictionary.
  2. In the Dictionary Bulk Actions section, select Create.
  3. Complete the fields in the Details section.
  4. 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 Report Type for the update. Leave this field blank to update Cases from all Report Types.
Case State Select the Case states you want to recode.
Study Type If the Report Type field is set to “Study”, you can select a Study Type for the recode.
Study If Study Type is populated, you can select a study for the recode.
Bulk Action Status This field is updated by the system when actions are run on the record. Statuses may be updated as follows:
  • Preview Generated: When the system has completed the Preview Bulk Recode action.
  • Bulk Action Initiated: When the system has started the Run Bulk Recode action.
  • Bulk Action Completed: When the system has completed the Run Bulk Recode action.

Prepare and Upload a Mapping File of Replacement Terms and Codes

To begin MedDRA bulk recoding, 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 Term
    • Replacement Version

Note Please be aware that mapping file columns cannot include commas. If a comma is included in any value, it is read as a separate item. This is a known limitation that will be addressed in a future release.

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. The system 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 one 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 only one 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

  1. Go to Business Admin > Dictionaries > MedDRA Dictionary.
  2. In the Dictionary Bulk Actions section, select a Bulk Dictionary Action record.
  3. 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.

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 Safety can generate this report for up to 20,000 Cases per file, based on unique Case IDs. The Cases are filtered based on the settings, such as Report Type and Case State, in the Dictionary Bulk Action record.

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

Result

The system generates the report. System and email notifications are sent 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:

  1. Open a new Excel file.
  2. Perform one of 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 dropdown, select Unicode (UTF-8).
  6. Under Delimiters, deselect Tab, and then select Comma.
  7. Perform one of 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.

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:

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

The 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.

See the following considerations when preparing a .csv file:

  • The file can include up to 20,000 Cases, based on unique Case IDs.
  • The column names must appear as shown below, in the following order:
    • Case
    • Case ID
    • WWUID
    • Object
    • Record ID
    • Field
    • Coded LLT
    • Coded LLT Term
    • Replacement LLT Code
    • Replacement Version

For more information on the column contents, see Preview CSV Format.

Note Once the Run Bulk Recode action has started, it cannot be cancelled. Only one bulk recode can be run at a time.

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

Result

The system initiates the recoding and the Bulk Action Status field updates to Bulk Action Initiated. System and email notifications are sent 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. A Summary Report becomes available for download.

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 > Dictionaries > MedDRA Dictionary > Bulk Dictionary Action > Attachments.

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 was recoded.
Record ID The Vault Record ID for the impacted field.
Field The Case field with the MedDRA code that was 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 a Follow-Up Case was created and recoded or if no action was taken.
Message If applicable, identifies errors on the file used for the recoding.

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