Controlled Terminology

Transcription

1 CDISC Italian User Group 16 November 2007 Controlled Terminology Cecilia Moresino Helsinn Healthcare

2 Controlled Terminology A finite set of values that represent the only allowed values for a data item. 2

3 Is it really necessary? A major problem facing the biomedical community is the wide variety of term used to express similar or identical concept AE Relatedness Example Company 1 No Unlikely Possible Probable Definite Company 2 Not related Doubtful Possible Probable Very likely Company 3 No Yes / unknown 3

4 Why adopt controlled terminology? To support and extend SDTM To allow exchange of data together with their meaning so that the data can be clearly understood and analysed To reduce ambiguity for submission reviewers To avoid home-made definition To comply with the autorities requirements 4

5 CDISC Controlled Terminology Initiative: Objective Define and support the terminology needs of the CDISC models across the clinical trial continuum (CDASH SDTM) 5

6 Harmonization Collaboration Liaison Status to ISO/TAG215 Submitted CDISC Standard as New Work Item ISO Terminology Task Force WHO International Clinical Trial Registry Platform Terminology Harmonization Terminology Development Terminology Publication Submission Standards Protocol Representation Critical Path Initiative data collection standards (CDASH) RCRIM Tech Committee BRIDG Model Protocol Representation w/ elements mapped to EudraCT Discussing all CDISC projects 6

7 Working Principals Evaluate and/or utilize available terminology first Expand existing terminology where incomplete, working with vocabulary developer / owner Harmonize across CDISC Models and with pre-existing vocabulary initiatives working closely with industry stakeholders, standards development organizations and vocabulary developers Ensure terminology meets international needs Ensure a sustainable environment for production terminology with support and maintenance required for terminology evolution 7

8 SDTM Terminology Projects The terminology Initiative is comprised of more than 50 team members (with representatives of FDA, NCI, Global Sponsors & CROs, Academia) distributed across 4 project teams SDTM Package-1: 30 code lists & more than 700 controlled terms - in Production Labtest: single code list with 92 controlled terms in Production; 200 additional Analyte terms in development Terminology SDTM Package-1 and Labtest Terms Final SDTM Package-2A: 12 code lists & more than 600 controlled terms for ECG (EG) & Interventions domains Concomitant Medication (CM), Drug Exposure (EX), and Substance Use (SU). This package includes a large set of harmonized terms for Units of Measure Public Review up to 17 August Terminology SDTM Package-2A SDTM Package-2B: 17 code lists & likely controlled terms for Adverse Events (AE), Physical Examination (PE), Vital Signs (VS) and Subjects Characteristics (SC) domains including Anatomical Location in Development (available for public review late summer 2007) SDTM = Study Data Tabulation Model 8

9 SDTM Package-1 (N=30) Action Taken with Study Treatment Age Units Country Domain Abbreviation Ethnicity Dose Form Identification variable Category for Inclusion/Exclusion Not Done or Null Answer No / Yes/ Unknown Answers Outcome of Event Race ( deferred) Reason for Non- Completion Causality Route of Administration Severity / Intensity Sex Size Code System Organ Class Relation to Reference Period Age Group Type of Control Description of Trial Design Diagnosis Group Trial Indication Type Trial Blinding Schema Standard Toxicity Grade Trial Phase Trial Summary Parameter Type of Trial Vital Signs Test Name Units for Vital Signs 9

10 SDTM Packages 2A & 2B Interventions Events Findings Other Exposure AE Labs Incl/Excl Demog ConMeds Disposition Vitals SubjChar Relationships Supp Qualifiers Subst Use MedHist PhysExam ECG Comments Questionnaire Trial Design 10

11 Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term C66768 C66768 No Outcome of Event OUT OUT Outcome of Event A condition or event that is CDISC SDTM Adverse attributed to the adverse event Event Outcome and is the result or conclusion Terminology C48275 C66768 Unique Outcome numeric of Event FATAL code FATAL Grade 5; 5 of The the termination adverse event. of life (NCI) as a Death Related to result of an adverse event. Adverse Event C49494 C66768 randomly Outcome of generated Event NOT RECOVERED/NOT by NCIt NOT RECOVERED/NOT One of the possible results of Not Recovered or Not RESOLVED RESOLVED IMPORTANT an adverse event outcome Resolved and assigned to individual that indicates that the event Contains the descriptive C49498 C66768 Outcome of Event RECOVERED/RESOLVED RECOVERED/RESOLVED COLUMN: version of One of Currently the possible results of Recovered or Resolved CDISC controlled Defines terms if controlled terms may be an adverse event outcome the codelist and also referred (as per to SDTMIG as that indicates that the 3.1.1) event C49495 C66768 Outcome of added Event RECOVERED/RESOLVED to the codelist. RECOVERED/RESOLVED New terms One of the possible results of Recovered or Resolved This identifies WITH SEQUELAE WITH SEQUELAE an adverse event outcome with Sequelae Unique numeric may be code added the the codelist label This in the is SDTM this the is NCI the IG. preferred specific value assigned to existing to the codelist where the subject recuperated applicable but retained pathological C49496 C66768 SDTM Outcome parent of values synonyms As with Event RECOVERING/RESOLVING codelist as long names. as for they a the Codelist name Code, for expected a the term for as RECOVERING/RESOLVIN **NOTE are not One of the possible results of Recovering or CDISC G an adverse event outcome Resolving -light blue duplicates Preferred Codelist highlighting or Term synonyms in Name is identified repeated submissions. in for NCIt each Each is used to of the existing that indicates that the event is C17998 C66768 previous Outcome of Event UNKNOWN UNKNOWN U; Unknown Not known, not observed, not Unknown identify the terms. Column. controlled term belonging value to a corresponds to beginning The expectation of a new SDTM is that recorded, or refused. (NCI) C66770 C66770 Yes Units for Vital VSRESU codelist VSRESU Units for an Vital SDTM Signs The Codelist unit used to record and CDISC SDTM Unit for codelist and sponsors its applicable will use term the published set. Results describe the result of a test Vital Sign Result investigating a vital sign. (NCI) Terminology C25613 C66770 Units for Vital C49673 C66770 Units for Vital C49674 C66770 Units for Vital C42559 C66770 Units for Vital C49668 C66770 Units for Vital C44277 C66770 Units for Vital Name as indicated by controlled terminology as a standard % % Percentage A fraction or ratio with 100 Percentage understood as the baseline and codelists defined as light blue shading. BEATS/MIN BEATS/MIN Beats per Minute denominator. The number of (NCI) heartbeats Beats per Minute extensible This identifies (or "Yes") the CDISC may have terms measured per minute time. (NCI) added definition by the for sponsor a particular internally. This is the CDISC preferred name BREATHS/MIN BREATHS/MIN Breaths per Minute The number of breaths Breaths per Minute term. In many cases an for a term (inhalation as and exhalation) identified in NCIt and taken per minute time. (NCI) existing NCI definition has to which numeric codes (Column been used. The source for A) are assigned. In most cases, C C Degree Celsius A unit of temperature of the Degree Celsius temperature scale designed so that the freezing point of the Preferred Term or PT is water is 0 degrees and the cm cm Centimeter A basic unit of length in Centimeter redundant former CGS with version of the metric "CDISC system, equal to one Submission hundredth of a Value" meter or previous F F Degree Fahrenheit The Fahrenheit temperature Degree Fahrenheit Column scale is named after the German physicist Gabriel Fahrenheit ( ), who proposed it in In this a definiton is noted in parentheses (e.g. NCI, CDISC glossary, FDA) 11

12 For the future Finalize production release of Labtest, SDTM Package 2A and SDTM Package 2B term sets Continue to increase team membership (65+ in 2007) with broader international coverage Further refine terminology development / production processes for faster release cycles Develop user guidelines for production terminology access, download and implementation Harmonize and support important future CDISC projects like CDASH, BRIDG, SEND and project initiated by ISO, ICH & WHO Further develop terminology education and training, including workshops and online tutorials CDASH = Clinical Data Acquisition Standards Harmonization BRIDG = Biomedical Research Integrated Domain Group 12

13 Questions 13