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CDISC SDTM v 1.5 For New Jersey CDISC User Group October 21, 2015 By Joyce Hernandez

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Presentation on theme: "CDISC SDTM v 1.5 For New Jersey CDISC User Group October 21, 2015 By Joyce Hernandez"— Presentation transcript:

1 CDISC SDTM v 1.5 For New Jersey CDISC User Group October 21, 2015 By Joyce Hernandez Jhernandez@eliassen.com

2 AGENDA New Variables – Interventions – Events – Findings – Pharmacogenomics (Genetic Variations) – Identifiers – All Observation Classes – Subject Disease Milestones – Domain specific CDISC SDTM V 1.5 210/21/2015

3 INTERVENTIONS --USCHFL – Unscheduled Flag – Added to support use case in the SEND model (DO NOT USE for Human Trials) Background: – Requested by pre-clinical reviewers – SEND’s concept of visit differs from human trials and they do not use TV nor SV CDISC SDTM V 1.5 310/21/2015

4 EVENTS --EVAL --EVALID --ACPTFL were added to the Events Class to support cardiovascular requirements and follows the same general rules as oncology --USCHFL – Unscheduled Flag – Added to support use case in the SEND model (DO NOT USE for Human Trials) CDISC SDTM V 1.5 410/21/2015

5 FINDINGS --NSPCES and --NSTRN initially introduced to support virology. Also supports other microorganisms and pathogens. --ORREF was added to represent a reference value associated with the collected result Use Cases: Reference sequence value and predicted normal value is spirometry tests based on certain demographics --STREFC Reference result in standard format (Derived or copied from –ORREF) --STREFN Numeric Reference Result in standard units CDISC SDTM V 1.5 510/21/2015

6 FINDINGS --IMPLBL – Implantation Site Label – Use Case: Fetal implantation site within the uterus (SEND example, no current clinical use case) --CHRON – Chronicity of Finding – categorizes the duration of a biological process e.g. ACUTE, CHRONIC, SUBACUTE (SEND and Human Trials) --DISTR – Distribution Pattern of Finding – pattern distribution within the examined area e.g. FOCAL, MULTIFOCAL, DIFFUSE, FOCAL MULTIFOCAL (SEND and Human Trials) CDISC SDTM V 1.5 610/21/2015

7 FINDINGS --LOBXFL – Last Observation Before Exposure Flag – Identifies the last non-missing value prior to RFXSTDTC. Use Case: Added to support transition from --BSFL to avoid conflict with ADaM baselines. --USCHFL – Unscheduled Flag – Added to support use case in the SEND model (DO NOT USE for Human Trials) --REPNUM – Repetition Number – Indicates the number of times a test was repeated within a given timeframe (i.e. same visit or within a timepoint) CDISC SDTM V 1.5 710/21/2015

8 FINDINGS (Genetic Variations) --GENRI - Genetic region of interest (e.g. KRAS) --GENTYP – Genetic region of interest type (GENE, PROTEIN, SECTOR) PFGENLI – Genetic Location of Interest of Target (location for targeted variation) PFGENTRG – Genetic Target (targeted variation) PFGENLOC – Genetic Location PFGENSR – Genetic Sub-region (e.g. Exon 15) PFRSNUM – Reference SNP number PFALLELC – Allele Identifier; differentiate between copies of a gene PFMUTYP – Mutation type (Indicates whether a variation is inheritable or not by the off-spring). Examples: Germline, Somatic CDISC SDTM V 1.5 810/21/2015

9 IDENTIFIERS --APID Associated Persons Identifier – identifier for a person who NOT a subject but is associated to a study, subject or a device FETUSID – Fetus Identifier – distinguishes a fetus from maternal subject for prenatal evaluations (DO NOT USE for Human Trials) --FOCID – Identification of a focus of study. Use Case from SEND – Injection Site 1, Injection Site 2 etc. From Ophthalmology: “OD” (right eye) --RECID Invariant Record Identifier – can be used to uniquely identify a record CDISC SDTM V 1.5 910/21/2015

10 ALL OBSERVATION CLASSES --NOMDY – Nominal Study Day – used to group observations which may be scheduled to occur in different days into a single day – used by collection or reporting systems (DO NOT USE for Human Trials) --NOMLB Label for Nominal Study Day – label used for the study day in a report (DO NOT USE for Human Trials) CDISC SDTM V 1.5 1010/21/2015

11 SUBJECT DISEASE MILESTONES MIDS – Disease Milestones Instance Name – Name of the milestone Example: HYPO1, HYPO2 etc. MIDSTYPE – Disease Milestone Type – Categorizes the milestone Example: HYPOGLYCEMIC EVENT Background: Document observations expected to occur in the course of the disease being studied and identify subjects undergoing these milestones 10/21/2015CDISC SDTM V 1.5 11

12 DOMAIN SPECIFIC EGBEATNO ECG Beat Number – A sequence number used to identify a beat within an ECG – qualifies EGORRES 10/21/2015CDISC SDTM V 1.5 12

13 10/21/2015CDISC SDTM V 1.5 13 QUESTIONS


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