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:
Bulk Recode Cases
To bulk-recode MedDRA terms on Cases:
- Create a Dictionary Bulk Action to specify the recode settings.
- Prepare and upload a mapping file of replacement terms and codes.
- Preview the bulk recode.
- Run the bulk recode.
- Optional: Download the MedDRA Bulk Recode 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 |
|
| 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 Approved/Closed Case Bulk Action Scope value you specify in the Dictionary Bulk Action:
- 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.
Bulk Recode Product-Event Combinations, Datasheets, Watchlists, and MedDRA Queries
To bulk-recode MedDRA terms on Product-Event Combinations, Datasheets, Watchlists, and MedDRA Queries:
- Create a Dictionary Bulk Action to specify the recode settings.
- Identify recode candidates.
- Preview the bulk recode.
- Run the bulk recode.
- Optional: Download the MedDRA Bulk Recode summary report.
Create a Dictionary Bulk Action
To create a Dictionary Bulk Action:
- Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
- Expand the Dictionary Bulk Actions section, then select Create.
- 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
- Hierarchy Bulk Recode Action: Bulk-recode MedDRA terms on Product-Event Combinations, Datasheets, Watchlists, and MedDRA Queries
- Complete the applicable fields, then select Save.
Dictionary Bulk Action Fields
The following fields may be available:
| Field | Description |
|---|---|
| Name | Enter a name for the action. |
| Dictionary | Vault populates MedDRA Dictionary. |
| Dictionary Bulk Action Type | Vault populates the action type. |
| Bulk Action Status | Vault populates a status whenever an action is run on the record. |
| Replacement MedDRA Version |
When creating a Case Bulk Recode Action, select the MedDRA version with the updated terms and codes. When creating a Hierarchy Bulk Recode Action, Vault populates the Latest Loaded MedDRA Version value on the MedDRA Dictionary. This represents the active MedDRA version in your Vault at the time the Dictionary Bulk Action was created. Upon completing bulk recode, Vault populates the MedDRA version used to complete the recode. Note: To create a Hierarchy Bulk Recode Action, Vault requires this field to have a value. To populate this field, download the latest central MedDRA dictionary version. |
| Approved/Closed Case Bulk Action Scope | When creating a Case Bulk Recode Action, select a value to define the Case versions Vault should consider for recoding. |
| Organization | Select the Organization for which you want to complete the recode. |
| Case State | When creating a Case Bulk Recode Action, select the states you want to recode. |
| Report Type | Optional: When creating a Case Bulk Recode Action, select a type for the update. Leave this field blank to update Cases from all types. |
| Study Type | Optional: If the Report Type value is Study, select a study type for the recode. |
| Study | Optional: If Study Type is populated, select a Study for the recode. |
| Hierarchy Level | When creating a Hierarchy Bulk Recode Action, select the level of the MedDRA hierarchy you want to consider for recoding. |
| Scope | When creating a Hierarchy Bulk Recode Action, select the object you want to consider for recoding. |
Prepare and Upload a Mapping File of Replacement Terms and Codes
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
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:
|
| Replacement Version | Each row must include the version number of the MedDRA Dictionary with the replacement LLT codes.
Note: A |
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:
- Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
- In the Dictionary Bulk Actions section, select a Dictionary Bulk Action.
- In the Attachments section, select Upload and then upload the
mapping.csvfile.
When you run the Preview Bulk Recode action, Vault uses the mapping.csv file to map non-current MedDRA codes to replacement codes.
Note: You cannot delete files after you upload them as attachments to Dictionary Bulk Actions. To replace an attached file, upload a new version with the same filename.
Identify Recode Candidates
To identify the Product-Event Combinations, Datasheets, Watchlists, or MedDRA Queries available for recoding:
- Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
- From the Dictionary Bulk Actions section, select the relevant Hierarchy Bulk Recode Action type of Dictionary Bulk Action.
- 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 latest loaded MedDRA version.
- Generates a CSV file titled
recode_list.csvcontaining 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
To generate a report detailing the object records that will be impacted by the MedDRA Bulk Recode:
- Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
- Expand the Dictionary Bulk Actions section, then select a Dictionary Bulk Action.
- In the All Actions menu, select Preview Bulk Recode.
Vault generates a CSV file titled preview.csv based on the mapping.csv or recode_list.csv 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:
- 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.csvfile 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.
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 Dictionary Bulk Action record.
Preview CSV Format for Cases
The following table describes the columns supported in the preview.csv file for Cases, 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
To bulk-recode MedDRA terms:
- Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
- Expand the Dictionary Bulk Actions section, then select a Dictionary Bulk Action.
- From the All Actions menu, select Run Bulk Recode.
- On the Confirmation page, select a
preview.csvfile1 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 audit trail 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 with an overview of the recode results
Note: 1. When bulk recoding Cases, you can use the preview.csv file generated by Vault, or you can upload your own CSV file to the Attachments section of the Dictionary Bulk Action, provided it is formatted to match the preview.csv file format, with the columns in the same listed order. The preview.csv file can include up to 20,000 Cases, based on unique Case IDs.
Download the MedDRA Bulk Recode 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:
- Navigate to Business Admin > Objects > Dictionaries > MedDRA Dictionary.
- Expand the Dictionary Bulk Actions section and select a Dictionary Bulk Action.
- From the Dictionary Bulk Action, expand the Attachments section and locate the relevant file.
- From the All Actions menu, select Download.
Summary Report Details for Case Recoding
Upon recoding Cases, the summary report includes the following columns:
| 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 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. |
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:
| Column Name | Description |
|---|---|
| Object | The object record with the MedDRA code that Vault recoded. |
| Object Type | The object type. |
| Record ID | The Vault ID for the impacted object record. |
| Field | The field with the MedDRA code that Vault recoded. |
| Hierarchy | The level of the MedDRA hierarchy that Vault recoded. |
| Current MedDRA ID | The original MedDRA ID on the object record. |
| Current MedDRA Code | The original MedDRA code on the object record. |
| Current MedDRA Term | The original MedDRA term on the object record. |
| Replacement MedDRA ID | The updated MedDRA ID. |
| Replacement MedDRA Code | The updated MedDRA code. |
| Replacement MedDRA Term | The updated MedDRA term. |
| Replacement Version | The version number of the MedDRA Dictionary with the replacement MedDRA code. |
| Message | If applicable, identifies errors on the file used for the recoding. |