Mastering Controlled Vocabularies (CVs) to faciliate succesful Regulatory Information Management...

Mastering Controlled Vocabularies to facilitate successful Regulatory

Information Management

Michiel Stam

Regulatory Operations Consultant

Qdossier B.V.

2Mastering CVs to facilitate sucesssful RIM

Agenda

23/05/2014

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

23/05/2014 4Mastering CVs to facilitate sucesssful RIM

“the collection and management of information from one or more sources…

…and the distribution of that information to one or more audiences

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”

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

Structure: CVs, taxonomies and thesauri

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)

Extended release tablet

Prolonged release tablet

Vocabulary challenges – Synonyms (II)

Saline

Sodium Chloride

= Different spelling, same meaning

Vocabulary challenges – Homographs

Coenzyme

Certificate of Analyses

Abbreviation “COA”?

= Same spelling, different meaning

Clinical Outcome

Assessment

Vocabulary challenges - difference in detail

Arginine glutamate

Arginine

L-Arginine

Arginine monoglutamate

Challenges of managing semantics – Personal preferences

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

Data granularity challenges (II)

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)

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

“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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Packaging CV

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Immediate container or administration device? >

prefilled or empty syringe?

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Needle = administration device or closure?

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Container = Syringe?

Need for Scope Notes/

Definition of terms!

Same, same but different..

“Same” audience, same dosage but different...

Mastering Vocabularies

Practical example: CITRIC ACID MONOHYDRATE

“Roots for Lemons”

WYSIWYG?

EMA SUBSTANCE CV (I)

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SUB12639MIG CITRIC ACID

SUB12482MIG CITRIC ACID MONOHYDRATE

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)

Alias or Greek translation?

Unique ID?

Translation of preferred term or alias translation?

Malti or English?

EU Telematic Controlled Terms

EUTCT - Controlled Term Lists

EUTCT – Authorisation Status

EUTCT – Expired due to Sunset Clause

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..)

MeSH – Medical Subject Headings Browser

Thesaurus principles

23/05/2014

• Broader and narrower terms• Preferred term and definition• Aliases• Translations• Reference sources• Relationships with other

terms• Unique identifier

Thesaurus Example

Mapping terminology

ISO 11239 Controlled VocabulariesPharmaceutical dose form CV examples

23/05/2014 Mastering CVs to facilitate sucesssful RIM

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?

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

MedDRA <> ICD-10 “Complete confidence”

Perfect match

MedDRA <> ICD-10 “Relative confidence”

No loss of information, slightly broader term

MedDRA <> ICD-10 “out of scope”

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No match possible

Developing a CV or Taxonomy

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/

Important basic ISO standards

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

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

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

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

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

Developing a CV

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

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

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

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

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

Mastering Controlled Vocabularies (CVs) to faciliate succesful Regulatory Information Management...

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