Manage MedDRA Synonyms

Set up and manage MedDRA synonyms to support coding medical terms.

Sections in This Article

About MedDRA Synonyms

Administrators can configure MedDRA Synonyms with the centralized MedDRA dictionary to allow for more comprehensive auto-coding, allowing for synonyms, coding preferences, common typos, and deprecated terms to take on different codes without human intervention.

You can manually create and edit synonyms in Vault Safety, or bulk import synonyms from an external source using Vault Loader or the REST API.

To support more accurate and up-to-date MedDRA coding, you can enable the automatic creation of synonym candidates for reported terms when there is no existing match at the time of data entry. In addition, administrators can configure contexts in which a synonym should not be applied. For more information, see Enable MedDRA Synonym Field Exclusion and Candidate Auto-Creation.

Synonym Auto-Coding

During Inbox Item or Case processing data entry, when auto-coding a MedDRA field from a reported term, Vault Safety first searches for an exact match to an active MedDRA Synonym. If there are multiple matching synonyms, they will be shown in the MedDRA browser.

If no exact match to a MedDRA synonym is found, the system then attempts to auto-code a match from the MedDRA dictionary.

If Synonym Candidate Auto-Creation is enabled, when no match is found, the reported term automatically becomes a synonym candidate. To become available for use, administrators must activate the synonym candidates.

Note To create a synonym candidate, you must save the Inbox Item or Case.

Considerations for MedDRA Synonyms

  • Synonyms are supported for the central MedDRA dictionary only.
  • Synonyms must be in the "Active" or "Updates" lifecycle states to be used in auto-coding.
  • If Synonym Candidate Auto-Creation is enabled, administrators can configure synonyms to be excluded from certain contexts, meaning they are not available in all MedDRA coding fields. If that feature is not enabled, field exclusions are not available for MedDRA synonyms.

Add a MedDRA Synonym Manually

  1. Go to Business Admin > MedDRA Synonyms.
  2. Select Create.
  3. Complete the fields on the Create MedDRA Synonym page.
  4. Select Save.
Add a MedDRA Synonym
Add a MedDRA Synonym

MedDRA Synonym Fields

Field Description
Verbatim (Required) Enter the verbatim (reported) term to match to this synonym for auto-coding. Verbatim terms must match this text exactly to be auto-coded using this Synonym (case-insensitive).
MedDRA Reference (Required) Code the MedDRA term PT/LLT that will be auto-coded to the verbatim term.
Excluded MedDRA Fields Select fields that cannot be coded with this Synonym.
MedDRA Languages Select the languages to which this Synonym applies.
Pending Count This field applies when the Synonym Candidate Auto-Creation feature is enabled. See more information in Synonym Candidate Auto-Creation.

Synonym Candidate Auto-Creation

When a user enters a verbatim reported term that is not found in the MedDRA Dictionary or MedDRA Synonym library, the term becomes a candidate to be a new MedDRA Synonym. The reported term is added to the MedDRA Synonym library in the New lifecycle state. The synonym must be moved to the Active lifecycle state to be available for auto-coding.

Synonym candidates are created when new verbatim reported terms are entered in the following fields:

Object Field
Inbox Item > Products
  • Indication (Reported)
Inbox Item > Medical Events
  • Event (Reported)
Case Product > Indication
  • Indication (Reported)
Case Adverse Event
  • Event (Reported)
Case Diagnosis
  • Name (MedDRA)
Case Cause of Death
  • Cause of Death (Reported)
Case Medical History & Concurrent Conditions
  • Condition/Procedure
Case Drug History
  • Indication (LLT)
  • Reaction (LLT)
Case Test Results
  • Test Name (Reported)

Note Synonym candidates cannot be auto-created from the following contexts:

  • Business Admin > Studies > Indication
  • Business Admin > Studies > Study Arm > Indication
  • Business Admin > Datasheets > Expected Adverse Events > MedDRA Term
  • Business Admin > Datasheets > Expected Adverse Events > Medical Condition

Manage MedDRA Synonym Candidates

  1. Go to Business Admin > MedDRA Synonyms.
  2. Select a synonym in the New lifecycle state, and then select Edit.
  3. Complete the fields.
  4. Optionally, expand the MedDRA Synonym Contexts section to see the context in which the synonym candidate was entered. The Context Link column is hyperlinked to the object and field.
  5. Select Save.
  6. Update the lifecycle state to Active.

Result

The MedDRA Synonym is now available for auto-coding.

How MedDRA Synonym Candidate Fields Are Populated Through Auto-Creation

Field Description
Verbatim The verbatim (reported) term entered on the Inbox Item or Case.
MedDRA Reference This is populated with a MedDRA term and code if one was entered the first time the synonym candidate was entered on an Inbox Item or Case.
Excluded MedDRA Fields This field is blank by default.
MedDRA Languages This is populated with the MedDRA language on the Inbox Item or Case. The default language is English.
Pending Count Displays the number of times that a synonym candidate has been entered. For each entry in the count, the MedDRA Synonym Contexts section includes a row with the following details:
  • The MedDRA Language from the Inbox Item or Case. The default is English.
  • The MedDRA Term and Code, if entered.
  • A hyperlinked Context Link to the Object and Field in which the synonym candidate was entered.

Updates to MedDRA Synonyms

When an Active MedDRA Synonym is coded to a new MedDRA term, the MedDRA Synonym record status changes to “Updates”. The Pending Count restarts at 1 and a new MedDRA Synonym Context record is added.

Synonyms in Updates status are still available for auto-coding. The system applies the term in the MedDRA Reference field.

Once updates are reviewed, Administrators can edit the MedDRA Reference field if needed, and then change the state back to Active.

Note To make a MedDRA Synonym inactive, change the state to Inactive.

Bulk Import MedDRA Synonyms

You can bulk import synonyms from an external source using Vault Loader or the REST API. The following resources provide information on these tools:

The following example shows the syntax for a sample Vault Loader .csv that can be loaded to bulk import MedDRA synonyms:

verbatim__v,meddra_code__v
Rash with itching,10023092
Rash on nose,10037873
Rash on nose,10037856
haemorrhage,10019524
headache recurrent,10019211
recurrent headache,10019211
headache occuring,10019211
occurin headache,10019211

Manage the MedDRA Dictionary
Bulk Recode MedDRA-Coded Terms on Cases
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