Innovative Medicines InitiativeWEB-RADR 2

Webinar 2: terminology mappings

@WEBRADR #WEBRADR2020

David Lewis, Novartis

Phil Tregunno, MHRA

@WEBRADR #WEBRADR2020

Welcome

WEB-RADR

Vision

#WEBRADR2020

Aims of the webinar

• WEB-RADR 2 outputs and achievementsShare

• Enhanced data exchange through terminology interoperabilityInspire

• Further discussion and collaborationInitiate

Webinar 2: terminology mappings

Jane Millar, SNOMED International

Speakers

Patrick Revelle, MedDRA MSSO

Judy Harrison, MedDRA MSSO

Judy Harrison, MedDRA MSSO

Jane Millar, SNOMED International

Patrick Revelle, MedDRA MSSO

@WEBRADR #WEBRADR2020

Work Package 4: Terminology Mapping And Maintenance

Terminology interoperability

• Longstanding need to exchange data between Electronic Health Record systems and the drug regulatory space based on standardised terminologies in order to support better public health information and patient safety

• Aim to achieve interoperability through maps between SNOMED CT (healthcare systems) and MedDRA (regulatory arena)

Facilitates conversion of SNOMED CT-encoded EHR data to MedDRA as a source for adverse event reporting

Allows MedDRA-coded data on product labels to be accessible in clinical decision support systems using the MedDRA to SNOMED CT map

• First time that the terminology owners, ICH and SNOMED International, have collaborated to produce endorsed standardised maps

• Sustainability of the work beyond the project by continued maintenance of the maps is a key aspect

Work Package 4

WP 4 - “Terminology Mapping and Maintenance”

Co-leads: Patrick Revelle (MSSO) and Jane Millar (SNOMED International)

Aims:

• Develop bi-directional independent maps between SNOMED CT and MedDRA based on a priority set of MedDRA content

• Develop ownership, maintenance, licensing and distribution arrangements between ICH and SNOMED International to enable sustainable implementation beyond the end of the project

Source data for mapping

• List of Terms to Map (Bi-directional)

7,349 MedDRA LLTs

Derived from EMA and MHRA, UK reported terms

Included adverse events, medical history, and indications

All 27 SOCs represented

Included terms from EMA’s Designated Medical Event (DME) list

Mapping teams and process

• Dual independent mapping

• Quality assurance

• Knowledge of SNOMED CT and MedDRA required

• Team 1• Sandra Fielder (AbbVie) - Mapper

• Martin Menke (CSL Behring) – Mapper

• Sophie Reeve, Tamara Darwiche (MHRA) – Quality Assurance

• Team 2• Isabel Lázaro Salcedo (AEMPS) - Mapper

• Belen Castro (AEMPS) – Mapper

• Kine Toure Lam (AEMPS) – Mapper

• Debbra Scotti (Pfizer) – Quality Assurance

• Maintenance Organization Quality Assurance• SNOMED International – Donna Morgan, Krista Lilly

• MSSO – Ali Awan, Amanda Saunders, Judy Harrison

Map deliverables

• Two independent maps

MedDRA to SNOMED CT map (6,374 LLTs mapped to SNOMED CT Fully Specified Names (FSN))

SNOMED CT to MedDRA map (3,684 FSNs mapped to LLTs)

Spreadsheet and RF2 formats

• Mapping conventions

Developed and revised through project

Available to users to understand how maps were created and to interpret results obtained

To be used for ongoing maintenance and updating

Map examples

• MedDRA to SNOMED CT

• SNOMED CT to MedDRA

Post-project steps

15

Nov 2019Bi-directional Term Mapping Complete

Feb 2020IMI Project Complete

March 2020Alpha Test Period Begins

- Scope includes format and content - Test Protocol Developed

- Regulatory, Industry, Vendor, Clinical Users, and Member country Testers

Identified

Sept 2020Alpha Test Period Ends

April 2021Production Version of the Maps

made available to licensed SNOMED/MedDRA Users

Alpha test/review of maps

• Alpha test/review period - April to September 2020

• Based on MedDRA version 21.1 (released September 2018) and SNOMED CT January 2019 International edition

• Purpose:Provide feedback on the quality and accuracy of the content of the maps

Provide feedback on the technical representation in the SNOMED CT RF2 version.

• Participants from stakeholder communities of both MedDRA and SNOMED InternationalParticipants must be a licensee of either MedDRA or SNOMED CT (or both)

• Participants are Regulators, Industry, Vendors, Researchers, Clinicians, Informaticians/Terminologists, SNOMED International Member Countries

• This period is intended to signal to both SNOMED CT and MedDRA communities and wider stakeholders the availability of these maps, which are new products to both organisations.

Alpha test/review of maps

• Participants are invited to complete a protocol questionnaire or provide ad hoc feedback

• In providing feedback, respondees are asked to provide details of the Use Cases they have applied when reviewing the maps, details of any data that has been used in comparison and also any specific areas of the Maps which are relevant

• The mapping conventions document has been shared so that reviewers can comment on how they supported the understanding of how the maps were created.

• As well as review of the Maps, respondees are asked to compare them to any similar maps they might have access to, though taking into account the issue of versioning etc.

• Comments on format and technical issues are invited, depending on which version they have used for review. Details of any software that have been applied are requested.

Any queries on this topic, contact either SNOMED International at info@snomed.org or mssohelp@meddra.org.

Alpha test/review protocol

Plans after alpha test

• Analyse Alpha Test/Review Feedback – October 2020

Consider content and format changes to the maps

Note that scope of maps remain the same

• Update maps to SNOMED CT International Edition January 2021 and MedDRA September 2020 – January/February 2021

• Extend the scope of the maps to include relevant COVID-19 terms

SNOMED CT and MedDRA both added COVID-19 terms during this period

• Complete the agreement between ICH and SNOMED International for maintenance of Maps

Sustainability of the maps beyond the WEB-RADR 2 project

Manage any further requirements, ensuring the maps meet the needs of users

• Production release of the 2 Maps - April 2021

Mapping maintenance

• Process developed during initial mapping within WEB-RADR 2 project

Consider content and format changes to the mappings

• Will support proposed additions and changes

SNOMED CT and MedDRA users will be able to submit change requests

Mapping maintenance (continued)

• Access and Distribution

Free to SNOMED CT and MedDRA users

RF2 for distribution to SNOMED CT users

Spreadsheets currently for distribution to MedDRA users

• SNOMED International and MSSO will form a project team to maintain the maps

Key is to sustain the quality of the maps as user needs evolve and as both terminologies develop

@WEBRADR #WEBRADR2020

Question and answer

Phil Tregunno, MHRA

@WEBRADR #WEBRADR2020

Concluding remarks

Next steps

@WEBRADR

Thank you for joining

Contact email: WEB-RADR@mhra.gov.uk

WEB-RADR website: https://web-radr.eu/

Webinar recording available on WEB-RADR website Events page:

https://web-radr.eu/events/

@WEBRADR

#WEBRADR2020

Innovative Medicines InitiativeWEB-RADR 2

Stakeholder-focused webinars

@WEBRADR #WEBRADR2020