Mastering Controlled Vocabularies to facilitate successful Regulatory
Information Management
Michiel Stam
Regulatory Operations Consultant
Qdossier B.V.
2Mastering CVs to facilitate sucesssful RIM
Agenda
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Introduction RIM & Controlled Vocabularies (CVs)
Controlled Vocabulary Challenges
Context of Use
Mapping terminology
Mastering Vocabularies (example)
Developing a CV or Taxonomy
Conclusions
Introduction RIM & Controlled Vocabularies
Regulatory Information Management
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“the collection and management of information from one or more sources…
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…and the distribution of that information to one or more audiences
Controlled Vocabularies (I)
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“provide a interpretive layer of semantics between underlying database and term entered by user to better represent the original intention of the terms”
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Controlled Vocabularies (II)
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Translation: converting natural language into vocabulary fit for indexing and retrieval
• commonly understood language to enable communication and knowledge exchange among stakeholders
Consistency: promote uniformity in format and use of terms
Indication of relationships: semantic relationships across terms• Solve the problems of Ambiguity (e.g. homographs and
synonyms)
Retrievability: optimize searches
Structure: CVs, taxonomies and thesauri
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represent increasing levels of complexity
Use terms from list only
Parent-child relations
Relationships beyond parent-childCustomized
semantic relationships
Vocabulary challenges
Vocabulary challenges – Synonyms (I)
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Extended release tablet
Prolonged release tablet
Vocabulary challenges – Synonyms (II)
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Saline
Sodium Chloride
Salt
NaCl
= Different spelling, same meaning
Vocabulary challenges – Homographs
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Coenzyme
Certificate of Analyses
Abbreviation “COA”?
= Same spelling, different meaning
Clinical Outcome
Assessment
Vocabulary challenges - difference in detail
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Arginine glutamate
Arginine
L-Arginine
Arginine monoglutamate
Challenges of managing semantics – Personal preferences
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Other challenges managing terminologies
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Spelling variations (and word ordering)• WATER FOR INJECTION• WATER FOR INJECTIONS• WATER-FOR-INJECTION• WATER-FOR-INJECTIONS
Data granularity
Transformation of data
Data granularity challenges (II)
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XEVPRM
Product Strength name: 4.2% w/v
Product Generic name: Sodium BicarbonateProduct Form name: Intravenous Infusion
Product Company name: Q-pharma
Product Short name: N/AProduct Reference name: BP
Data granularity challenges (IV)
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IDMP
Scientific name part
Invented name part Sodium Bicarbonate
Intended Use part
Strength part: 4.2% w/v
Pharmaceutical dose form part Intravenous Infusion
Formulation part
Target Population part
Container or Pack part
Device part
Trademark or Company Name part Q-pharma
Time/Period part
Flavour part
Product Generic Name = Invented name part
Challenges when transforming data
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SmPC:
“Prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy”
MedDRA:• Prophylaxis of nausea and vomiting (LTT)
• Chemo induced not available
• Prophylaxis against radiation induced nausea and vomiting (LLT)
• Nausea post chemotherapy (LLT)• Nausea post radiotherapy not available
• Vomiting post chemotherapy (LLT)• Vomiting post radiotherapy (LLT)
natural language > coded data
Context of Use
Mastering CVs to facilitate sucesssful RIM
Packaging definition IDMP
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Mastering CVs to facilitate sucesssful RIM
Packaging definition IDMP
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Packaging CV
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Packaging definition IDMP
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Immediate container or administration device? >
prefilled or empty syringe?
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Packaging definition IDMP
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Needle = administration device or closure?
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Packaging definition IDMP
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Cap?
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Packaging definition IDMP
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Container = Syringe?
Need for Scope Notes/
Definition of terms!
Mastering CVs to facilitate sucesssful RIM
Same, same but different..
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“Same” audience, same dosage but different...
Mastering Vocabularies
Practical example: CITRIC ACID MONOHYDRATE
“Roots for Lemons”
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WYSIWYG?
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EMA SUBSTANCE CV (I)
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SUB12639MIG CITRIC ACID
SUB12482MIG CITRIC ACID MONOHYDRATE
Mastering CVs to facilitate sucesssful RIM
SUB76183 CITRIC ACID MONOHYDRATE N/A Substance Preferred Name
SUB76183 MONOHYDRATED CITRIC ACID N/A Substance Alias
SUB76183 MONOHYDRIC CITRIC ACID N/A Substance Alias
SUB76183 ΚΙΤΡΙΚΟ ΟΞΥ ΜΟΝΟΥΔΡΙΚΟ N/A Substance Alias
SUB76183 ACID CITRIC MONOHIDRAT RO Substance Translation
SUB76183 ACID CITRIC MONOHIDRAT (PENTRU REGLAREA PH-ULUI) RO Substance Translation
SUB76183 ACIDE CITRIQUE MONOHYDRATE FR Substance Translation
SUB76183 ACIDE CITRIQUE MONOHYDRATÉ FR Substance Translation
SUB76183 ACIDE CITRIQUE MONOHYDRATÉ (E330) FR Substance Translation
SUB76183 ACIDO CITRICO MONO-HIDRATADO PT Substance Translation
SUB76183 ÁCIDO CITRICO MONO-HIDRATADO PT Substance Translation
SUB76183 ÁCIDO CÍTRICO MONOHIDRATADO ES Substance Translation
SUB76183 ÁCIDO CÍTRICO MONOHIDRATADO PT Substance Translation
SUB76183 ÁCIDO CÍTRICO MONO-HIDRATADO PT Substance Translation
SUB76183 ÁCIDO CÍTRICO MONOHIDRATADO (E 330) ES Substance Translation
SUB76183 ÁCIDO CÍTRICO MONOHIDRATADO (E 330) PT Substance Translation
SUB76183 ÁCIDO CÍTRICO MONOHIDRATADO (PARA AJUSTE DO PH) PT Substance Translation
SUB76183 ÁCIDO CÍTRICO MONOHIDRATO ES Substance Translation
SUB76183 ACIDO CITRICO MONOIDRATO IT Substance Translation
SUB76183 ACIDO CITRICO MONOIDRATO (E330) IT Substance Translation
SUB76183 CITRATNA KISELINA HIDRAT HR Substance Translation
SUB76183 CITRIC ACID MONOHYDRATE MT Substance Translation
EMA SUBSTANCE CV (de-duplicated)
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Alias or Greek translation?
Unique ID?
Translation of preferred term or alias translation?
Malti or English?
EU Telematic Controlled Terms
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EUTCT - Controlled Term Lists
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EUTCT – Authorisation Status
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EUTCT – Expired due to Sunset Clause
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U.S. National Library of Medicine - Medical Subject Headings (MeSH)
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for indexing journal articles and books in the life sciences; and serves as a thesaurus that facilitates searching (since 1963..)
MeSH – Medical Subject Headings Browser
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Thesaurus principles
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• Broader and narrower terms• Preferred term and definition• Aliases• Translations• Reference sources• Relationships with other
terms• Unique identifier
Mastering CVs to facilitate sucesssful RIM
Thesaurus Example
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Mapping terminology
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ISO 11239 Controlled VocabulariesPharmaceutical dose form CV examples
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Managing different vocabularies for different audiences
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ISO IDMP
Local implementation A
Local implementation B
Local implementation C
Comparable data?MedDRA < > WHO ART <> ICD10 ?
Mapping relationships?
Broader and narrower terms?
EDQM < > SNOMED CT?
Mastering CVs to facilitate sucesssful RIM
ICD-10 and MedDRA mapping
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Both terminologies used for adverse event coding
• MeDRA Medical Dictionary for Regulatory Activities – Indications and reactions• E.g. SPC indication to MedDRA in XEVMPD
• ICD-10 International Classification of Diseases and Related Health Problems• E.g. SPC indication to ICD-10 in E-prescription system
Greece
MedDRA <> ICD-10 “Complete confidence”
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Perfect match
MedDRA <> ICD-10 “Relative confidence”
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No loss of information, slightly broader term
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MedDRA <> ICD-10 “out of scope”
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No match possible
?
?
Developing a CV or Taxonomy
Vocabulary standards
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ANSI/NISO Z39.19-2005 Guidelines for the Construction, Format and Management of Monolingual CVs
• http://www.niso.org/apps/group_public/download.php/12591/z39-19-2005r2010.pdf
New ISO 25964 thesaurus standard• http://www.niso.org/schemas/iso25964/
Important basic ISO standards
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Importance
Standard Identifier Standard Name Topics Related Standards
639 Codes for the representation of names of languages [3 Parts]
Language Codes
Very 704 Terminology work — Principles and methods Definitions, Objects, Concepts
/IEC 11179-4 Information technology — Metadata registries () — Part 4: Formulation of data definitions
860 Terminology work – Harmonization of concepts and terms
Concepts, Terms
Very 1087-1 Terminology work — Vocabulary — Part 1: Theory and application
Objects, Concepts, Definitions, Designations
/IEC 2382 Information technology — Vocabulary [Many Parts] Vocabulary2788 Documentation - Guidelines for the establishment
and development of monolingual thesauriThesaurus, Terms
3166-1 Codes for the representation of names of countries and their subdivisions - Part 1: Country codes
Country Codes
5964 Documentation - Guidelines for the establishment and development of multilingual thesauri
Thesaurus, Terms
Very TR 9007 Information processing systems - Concepts and terminology for the conceptual schema and the information base
Conceptual Schema
/IEC 9834 Information technology - Open Systems Interconnection - Procedures for the Operation of Registration Authorities [Many Parts]
Identifiers
Very /IEC TR 10032 Information technology — Reference Model for Data Management
Database
/IEC 11179-1 Information technology — Metadata registries () — Part 1: Framework
Registry for data elements and their components
Developing a CV
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Scope
Build
Publish
Review
Maintain
• In Scope < > Out of scope• Scope Notes restricted to selected
meanings within domain • Reference sources (e.g. databases,
external vocabularies)• avoid duplicating existing CVs
• Maintenance plan (rules for creation, status change, relationships and restructuring)
• Define structure of CV
Developing a CV
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Scope
Build
Publish
Review
Maintain
• Collecting terms • top-down (BT > NT)• bottom up (NT > BT)• deductive method
• machine assisted (e.g. queries, frequency of use)
• Organizing terms (parent-child, preferred and non-preferred, abbreviations etc)
• Granularity of terms
Grammar and spelling
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Verbs expressed as infinitives should be avoided, e.g.;
• Analyses rather then analyze• Publishing rather then publish
British English or American English spelling?
Abbreviations used as terms only if well established
• e.g. eCTD rather electronic Common Technical Document
Many grammatical rules: refer to ANSI/NISO Z39.19-2005 (R2010)!!!
Developing a CV
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Scope
Build
Review
Maintain
• Export terms in machine-readable language, e.g.:• Web Ontology Language
(OWL)• Simple Knowledge
Organization System (SKOS)• RDF-S• XML
• User documentation• Type of display
Publish
User Interface
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Developing a CV
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Scope
Build
Publish
Review
Maintain
• SME review process• form, completeness,
consistency • Technical validation
• RDF/SKOS/XML files• Error checking
• (potential) duplicates• Usability test
• retrievability
Developing a CV
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Scope
Build
Publish
Review
Maintain
• Policy and procedures on periodic review (addition, modification and deletion of terms)• Term request form
• Term statusCandidate/ Provisional (terms not admitted until review)ApprovedNot valid• Versioning & HistoryCreate date and modified date
Conclusions and recommendations
Conclusions
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Semantic challenges can impact information retrievability
Controlled Vocabularies help to understand original intention of information
No one-size fits all; vocabularies differ per audience
Leverage from existing standards; do not copy
Thank you !
Questions?
Scope notes
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Used to restrict or expand usage of a term
To distinguish between terms with overlapping meanings
To provide other advice on term usage to indexer or searcher
Must state the chosen meaning of a term
May state other meanings of a term
Use of Qualifiers
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Use compound terms rather then qualifiers, if available in language
• e.g. clinical study <> study (clinical)
Consider reuse CV across other domains• e.g. sequence > ectd sequence vs. dna sequence
Standardize Qualifiers • e.g. use of clinical study and clinical trial
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