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
– SEND’s 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