How controlled vocabularies can facilitate regulatory information management and overcome the challenges of managing different vocabularies.

1. Mastering Controlled Vocabularies to
facilitate successful Regulatory
Information Management
Michiel Stam
Regulatory Operations Consultant
Qdossier B.V.

2. Agenda
Introduction RIM & Controlled
Vocabularies (CVs)
Controlled Vocabulary Challenges
Context of Use
Mapping terminology
Mastering Vocabularies (example)
Developing a CV or Taxonomy
Conclusions
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3. Introduction
RIM & Controlled Vocabularies

4. Regulatory Information Management
“the collection and management of information from one
or more sources…
…and the distribution of that information to one or more
1
audiences
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5. Controlled Vocabularies (I)
“provide a interpretive layer of semantics between
underlying database and term entered by user to better
represent the original intention of the terms”
1
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6. Controlled Vocabularies (II)
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
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7. Structure: CVs, taxonomies and thesauri
represent increasing levels of complexity
Use terms
from list only
Parent-child
relations
Relationships
beyond
Customized parent-child
semantic
relationships
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8. Vocabulary challenges

9. Vocabulary challenges – Synonyms (I)
Extended
release tablet
Prolonged
release tablet
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10. Vocabulary challenges – Synonyms (II)
10
Saline
Sodium
Chloride
Salt
NaCl
= Different spelling, same meaning
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11. Vocabulary challenges – Homographs
Coenzyme
Certificate of
Analyses
Abbreviation “COA”?
Clinical
Outcome
Assessment
= Same spelling, different meaning
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12. Vocabulary challenges - difference in detail
Arginine
glutamate
Arginine
L-Arginine
Arginine
monoglutamate
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13. Challenges of managing semantics –
Personal preferences
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15. Other challenges managing terminologies
Spelling variations (and word ordering)
• WATER FOR INJECTION
• WATER FOR INJECTIONS
• WATER-FOR-INJECTION
• WATER-FOR-INJECTIONS
Data granularity
Transformation of data
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16. Data granularity challenges (II)
XEVPRM
Product Strength name: 4.2% w/v
Product Generic name: Sodium Bicarbonate
Product Form name: Intravenous Infusion
Product Company name: Q-pharma
Product Short name: N/A
Product Reference name: BP
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17. Data granularity challenges (IV)
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
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18. Challenges when transforming data
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)
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19. Context of Use

20. Packaging definition IDMP
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21. Packaging definition IDMP
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22. Packaging definition IDMP
Immediate container or
administration device? >
prefilled or empty syringe?
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23. Packaging definition IDMP
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Needle = administration
device or closure?
Mastering CVs to facilitate sucesssful RIM

24. Packaging definition IDMP
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Cap?
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25. Packaging definition IDMP
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Container = Syringe?
Mastering CVs to facilitate sucesssful RIM

26. Same, same but different..
“Same” audience, same dosage but
different...
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27. Mastering Vocabularies
Practical example: CITRIC ACID MONOHYDRATE

28. “Roots for Lemons”
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29. EMA SUBSTANCE CV (I)
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SUB12639MIG CITRIC ACID
SUB12482MIG CITRIC ACID
MONOHYDRATE
Mastering CVs to facilitate sucesssful RIM

30. EMA SUBSTANCE CV (de-duplicated)
Alias or Greek
translation?
Unique ID?
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
Translation of
preferred term or
alias 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
Malti or English?
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
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31. EU Telematic Controlled Terms
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32. EUTCT - Controlled Term Lists
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33. EUTCT – Authorisation Status
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34. EUTCT – Expired due to Sunset Clause
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35. U.S. National Library of Medicine - Medical
Subject Headings (MeSH)
for indexing journal articles and books in
the life sciences; and serves as a
thesaurus that facilitates searching (since
1963..)
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36. MeSH – Medical Subject Headings Browser
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37. Thesaurus principles
• Broader and narrower terms
• Preferred term and definition
• Aliases
• Translations
• Reference sources
• Relationships with other
terms
• Unique identifier
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38. Thesaurus Example
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39. Mapping terminology

40. 40
ISO 11239 Controlled Vocabularies
Pharmaceutical dose form CV examples
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41. Managing different vocabularies for different
audiences
ISO
IDMP
Local implementation A
Local implementation B
Local implementation C
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42. ICD-10 and MedDRA mapping
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
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43. MedDRA <> ICD-10 “Complete confidence”
Perfect match
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44. MedDRA <> ICD-10 “Relative confidence”
No loss of information, slightly broader
term
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45. MedDRA <> ICD-10 “out of scope”
No match possible
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46. Developing a CV or Taxonomy

47. Vocabulary standards
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/
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48. Important basic ISO standards
Importanc
e
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] Vocabulary
2788 Documentation - Guidelines for the establishment
and development of monolingual thesauri
Thesaurus,
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
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49. Developing a CV
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
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50. Developing a CV
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
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51. Grammar and spelling
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
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52. Developing a CV
Scope
Build
Publish
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
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53. User Interface
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54. Developing a CV
Scope
Build
Publish
Review
Maintain
• SME review process
• form, completeness,
consistency
• Technical validation
• RDF/SKOS/XML files
• Error checking
• (potential) duplicates
• Usability test
• retrievability
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55. Developing a CV
Scope
Build
Publish
Review
Maintain
• Policy and procedures on periodic
review (addition, modification and
deletion of terms)
• Term request form
• Term status
Candidate/ Provisional (terms
not admitted until review)
Approved
Not valid
• Versioning & History
Create date and modified date
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56. Conclusions and
recommendations

57. Conclusions
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
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58. Thank you !
Questions?

59. Scope notes
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
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60. Use of Qualifiers
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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