MedDRA Dictionary VersioningAmit Kulkarni, Principal Clinical Coding SpecialistHyderabadMarch 12, 2019

Centre of Excellence, Global Development Operations

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Disclaimer

• This presentation is based on publicly available information (including data relating to non-Novartis products or approaches)

• The views presented are the views of the presenter, not necessarily those of Novartis

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Outline• MedDRA Maintenance

• MedDRA Versioning• Overview• Methodologies• Impact

• Utility of MedDRA Version Analysis tool

• LexiCode (In-house sophistication program) Assistance in Up-versioning

• Timing for Version Implementation

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About MedDRA

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Prior to MedDRA

No internationally

accepted medical

terminology.Companies

used different medical

terminologies for

submissions to HAs.

Lack of specificity of terms at data entry level, limited data

retrieval options.

Necessitated conversion of data caused

time delays and distortion of

data.

Affected communication between HA’s –

pharma companies. The MedDRA

Managed by Maintenance and Support Services Organization (MSSO)

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MedDRA Maintenance (1/2)• MSSO allows subscribers to submit change requests.

• A monthly limit of 100 Change requests are allowed per

organization.

• MSSO physicians approve/reject these requests and

provide justifications.

• These change requests become the basis of dictionary

version upgrades

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MedDRA Maintenance (2/2)

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MedDRA Versioning (1/2)

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1 March X.0 release 1 September X.1 release

Complex release involves the changes in all levels from LLT-SOC

Simple release, this is limited to changes in

LLT and PT

Biannual release

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MedDRA Versioning (2/2)

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Goals of

versioning

Implement Current version of MedDRA

Stay current with requirement of regulators [3]

Harmonize use of MedDRA to optimize

communication of data

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MedDRA Versioning Methodologies

• The versioning strategy may differ between safety databases and clinical trial databases.

• “The points to consider document” describes these methodologies for dictionary version upgrade [4]

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Impact of Versioning (1/7)

• Release on 1 March 2019

• Change request summary: –MSSO considered 1,541change requests, including SMQ requests (not includingtranslation updates)

• Approved: 1,333

• Not approved: 207

• Suspended: 1

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Impact of Versioning (2/7) - MedDRA Version 22.0

• At the SOC level: No changes were made to existing SOCs.• At the HLGT level: There were two High Level Group Terms

(HLGTs) added and two merged as a result of complex changes in Version 22.0.

• At the HLT level: There were six High Level Terms (HLTs) added and six merged as a result of complex changes in Version 22.0

STANDARDISED MedDRA QUERIES (SMQs) • New SMQ Hypokalaemia was added in MedDRA Version

22.0. There are now 104 level 1 SMQs in production as of this version. Additionally, there were 389 approved changes to existing SMQs

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Impact of Versioning(3/7)

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Impact of Versioning (4/7)

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Report TitleTotal Changes between selected versions Report Selected?

New LLTs including New PTs 755 YesNew PTs 327 YesPromotions 42 YesDemotions 50 YesLLTs under different PTs 288 YesLLT (excl PT) Primary SOC Chg 22 YesPT Primary SOC Changes 4 YesMedDRA Term Name Changes 5 YesMedDRA Code Switches 0 YesCurrency Changes 11 YesComplex Changes 16 YesSMQ Changes 5 YesPT Changes in SMQs 421 Yes

Starting Version: MedDRA 21.1 EnglishEnding Version: MedDRA 22.0 English

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Impact of Versioning (5/7)

• Currency Changes: Non-Current to Current LLT

• Demotion of PT’s

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Demoted PT 22.0 PTAcute focal bacterial nephritis Nephritis bacterialBehavioral addiction Behavioural addictionChemical eye injury Chemical burns of eyeChemical iritis Chemical burns of eyeConduct disorder Behaviour disorder

LLT 21.1 Currency 22.0 CurrencyLumbar syndrome Non-Current CurrentPET scan Non-Current Current

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Impact of Versioning (6/7)

• Example of change in PT by version

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PT 21.1 Primary SOC 22.0 Primary SOCReactive gastropathy Gastrointestinal disorders Injury, poisoning and procedural complicationsAngular cheilitis Infections and infestations Gastrointestinal disordersAgitation neonatal Psychiatric disorders Nervous system disordersTracheobronchomegaly Respiratory, thoracic and mediastinal disCongenital, familial and genetic disorders

LLT 21.1 PT 22.0 PTTaste abnormality Dysgeusia Taste disorderTaste alteration Dysgeusia Taste disorderTaste altered Dysgeusia Taste disorderTaste changed Dysgeusia Taste disorderTaste disturbance Dysgeusia Taste disorder

• Example of change SOC by version

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Impact of Versioning (7/7)• Affects statistical analysis where summary is reported

by SOC / PT / SOC and PT

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MedDRA Version Analysis Tool (1/3) Search Term Change

• MedDRA Version Analysis tool can be accessed by https://tools.meddra.org/mvat

• MVAT tool helps to see the changes in data after a up-version.

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MedDRA Version Analysis tool (2/3)• Allows the user to find the changes between two different

MedDRA versions• Allows easier up version of terms coded in older version

of MedDRA, as part of data pooling.

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MedDRA Version Analysis tool (3/3) Data Impact Report

• Data Impact Report helps to find the impact between two MedDRA versions, in a clinical trial.

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LexiCode (In-house sophistication program) in Up-versioning

• Extraneous information reported by investigators makes it difficult for a human/tool to identify a better code in the subsequent MedDRA Version. LexiCode our in-house sophistication program to takes advantage of programming technologies to address this gap.

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Recommended Timing of Version Implementation• For single case reporting, the sender and receiver of

the data need to be in synchrony regarding MedDRA versions.

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Frequently Asked Questions in Webinars• Understanding the MVAT reports and what the tabs

mean?

• How to version a database which has a mix of versions included in it from applying the latest version over time and not doing regular version updates?

• How are version updates applied in clinical trials? What are the authority requirements? Best practices? Pros & Cons?

• Knowing which of the MVAT listed changes need to be applied to a dataset and how to do it? Which terms need recoding?

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References

• References for MedDRA Implementation and Versioning of Clinical trials [1]

• What’s New with MedDRA 22.0 [2]

• Electronic Study Data Submission; Data Standards; Support for Version Update of the Medical Dictionary for Regulatory Activities [3]

• Points to Consider document for MedDRA 22.0 [4]

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Thank you

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Additional Slides For Questions

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