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EHR

Disease Registry. EHR. Knowledge Base. SDTM. and other Auhortities. Clinical Trial Sponsor. Entry Form. Case Report Form. Outbreak Report. Safety Org. Adverse Event Data. Secondary Uses. Primary Use.

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EHR

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  1. Disease Registry EHR Knowledge Base SDTM and other Auhortities Clinical Trial Sponsor Entry Form Case Report Form Outbreak Report Safety Org. Adverse Event Data Secondary Uses Primary Use From Landen Bain’s presentation at the Clinical Observations Interoperability Telcon, 28 August 2007, with some minor additions relevant for Drug Development

  2. Primary use inDrug Development (i.e. Secondary Use of Health Care data in clinical research) Primary Usein Health Careper patient Secondary Usein Health Careas Knowledge Base Subject SDTM Auhortities Organizing clinical trials information that is to be submitted to the FDA. Patient Secondary UseEpi / Population / Real life analysis Secondary Usein Drug Developmentas Knowledge Base

  3. TRIAL DESIGN MODEL Trial Summary Parameter domaine.g AGESPAN and SEXPOP Trial Inclusion/Exclusion Criteria domain SDTM Auhortities Inclusion/Exclusion Criterion Not Met (findings domain)Refeering back to IETESTCD CLINICAL OBSERVATIONS per SUBJECT such as Demographics (special purpose domain) with fixed variables such as SEX, BRTHDTC, AGE / AGEU Vital Signs and Subject Characteristics (findings domain)Using Controlled Terminologies of Test Codes Medical History (events domain)Using MedDRA Concomitant Medications and Substance Use (interventions domain)

  4. Backup slides Background to SDTM

  5. CDISC SDTM and related initativies All terms and conceptsare incorporated from NCI Thesaurus thorugh NCI EVS SDTM variables specifiedas packages of ControlledTerminologies Published as an Excel matrixeson CDISC website In OWL format NCI Thesaurus CDISCClinical Data Interchange Standards Consortium UMLS RCRIM Regulated Clinical Research and Information Management,technical committee Relationship HL7/CDISC BRIDGBiomedical Research Integrated Domain Group Model HL7 “Health Level Seven”

  6. CDISC SDTM’s Domains Interventions Events Findings Other Exposure AE Labs Incl Excl* Demog ConMeds Disposition Vitals Subj Char* RELATES* SUPPQUAL* Subst Use* MedHist PhysExam ECG Comments* Study Design* QS*, MB* CP*, DV* Study Sum* From CDISC SDTM Overview & Impact to AZ, 2004, by Dan Godoy, presented at the first CDISC/SDM meeting 20 October 2004

  7. Basic Concepts in CDISC SDTMObservations and Variables • The SDTM provides a general framework for describing the organization of information collected during human and animal studies. • The model is built around the concept of observations, which consist of discrete pieces of information collected during a study. Observations normally correspond to rows in a dataset. • Each observation can be described by a series of named variables. Each variable, which normally corresponds to a column in a dataset, can be classified according to its Role. • Observations are reported in a series of domains, usually corresponding to data that were collected together. A domain is defined as a collection of observations with a topic-specific commonality about a subject. From the Study Data Tabulation Model document

  8. Basic Concepts in CDISC SDTMVariable Roles • Qualifier variables • Grouping Qualifiers • Result Qualifiers • Synonym Qualifiers • Record Qualifiers • Variable Qualifiers • Topic variables • Identifier variables • Timing variables • Rule variables An example of a SDTM dataset (Vital Sign domain) Observation Record RecordQual Topic Identifier Timing GroupingQual SynonymQual Res ResQual Var VarQual Generic dataset structure for all domainsBased on the descriptions in the Study Data Tabulation Model document

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