CDISC SDTM v 1.5 For New Jersey CDISC

CDISC SDTM v 1.5 For New Jersey CDISC User Group October 21, 2015 By Joyce Hernandez [email protected] AGENDA New Variables Interventions Events Findings Pharmacogenomics (Genetic Variations) Identifiers

All Observation Classes Subject Disease Milestones Domain specific 10/21/2015 CDISC SDTM V 1.5 2 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

SENDs concept of visit differs from human trials and they do not use TV nor SV 10/21/2015 CDISC SDTM V 1.5 3 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) 10/21/2015 CDISC SDTM V 1.5 4 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 10/21/2015 CDISC SDTM V 1.5 5 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) 10/21/2015 CDISC SDTM V 1.5 6 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) 10/21/2015 CDISC SDTM V 1.5 7

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 10/21/2015

CDISC SDTM V 1.5 8 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

10/21/2015 CDISC SDTM V 1.5 9 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)

10/21/2015 CDISC SDTM V 1.5 10 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

10/21/2015 CDISC SDTM V 1.5 11 DOMAIN SPECIFIC EGBEATNO ECG Beat Number A sequence number used to identify a beat within an ECG qualifies EGORRES 10/21/2015 CDISC SDTM V 1.5

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