SDTM IG 3.1.4x

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Transcript SDTM IG 3.1.4x

SDTM IG 3.1.4
(Batch 1 – Release for Public Review)
Standards for Therapeutic Areas
Quintiles QBLM SDTM Forum
Copyright © 2012 Quintiles
Part 1:
SDTM IG 3.1.4
(Batch 1 – Release for Public Review)
Quintiles QBLM SDTM Forum
Copyright © 2012 Quintiles
SDTM-IG 3.1.4 (Batch 1)
Given the volume of new specialty IG and domains, the SDS Team decided
to divide materials targeted for inclusion in SDTM-IG 3.1.4 into two manageable
batches for public review
• Batch 1 package:
Exposure Domains Supplement:
o Clarification on variables, Added/Updated Variables
o Variables proposed for Deprecation
o New domain is introduced, Exposure as Collected (EC).
Immunogenicity Domains Supplement:
Immunogenicity Specimen Assessments (IS)
Skin Response (SR) {Findings About Domain}
{Findings Domain}
Reproductive Details Domain Supplement:
o Reproductive Details {Findings Domain}
IG 3.1.4 (Batch 1)
Exposure Domains Supplement :
o Clarification on variables
o Added / Updated Variables
o Variables proposed for Deprecation
EX Domain:
 Recognized as a derived dataset
 Reflecting Subject Exposure:
to protocol-specified study treatment(s),
in protocol-specified unit(s)
 Reflecting collected information descriptive of doses not taken, not given
or missed
IG 3.1.4 (Batch 1)
Exposure Domains Supplement :
o Clarification on variables
 Values to reflect protocol-specified unit(s)
Derivation from collected unit to protocol-specified unit may be required
 Values to reflect the amount of active ingredient administered in protocolspecified unit
EXDOSE = Number of units (e.g., TABLET) multiplied by Pharmaceutical
Strength (active ingredient/unit), adjusted as-needed to protocol-specified unit.
 Values to reflect the total amount of the prepared product (treatment +
vehicle) administered
IG 3.1.4 (Batch 1)
Exposure Domains Supplement :
o Clarification on variables
o Added / Updated Variables
o Variables proposed for Deprecation
Added as permissible variables : EX domain
Definition Updates:
• --DOSE: SDTM definition updated by adding –DOSTOT to the following sentence:
‘Not populated when --DOSTXT or --DOSTOT is populated.’
• --REASND: SDTM definition expanded; used in conjunction with --STAT value of
‘NOT DONE’ or --OCCUR value of ‘N’.
IG 3.1.4 (Batch 1)
Interventions General Observation Class :
Identify records as either ‘SCHEDULED’ or ‘PERFORMED’.
Describe the fasting status at the time of the administration
Describe the method of administration
Reflect the pharmaceutical strength of a treatment
defined as the content of an active ingredient expressed
quantitatively per dosage unit, per unit of volume, or per unit
of weight, according to the pharmaceutical dose form
Reflect the associated unit of the pharmaceutical strength
(e.g., mg/mL, mg/TABLET).
Represent the number of doses taken within an interval of
time defined by --STDTC and --ENDTC or --DUR.
IG 3.1.4 (Batch 1)
General Observation Class :
Represent the method of observation (e.g., OBSERVED,
SUBJECT RECALL). If more than one value applies at the
record-level, then --MTHOBS should be populated.
Permissible Timing variable to indicate if an intervention or
event occurred at a point in time. If ‘Y’, then --ENDTC must
be null. If null, then --ENDTC or --DUR should be populated
IG 3.1.4 (Batch 1)
Exposure Domains Supplement :
o Clarification on variables
o Added / Updated Variables
o Variables proposed for Deprecation
 was not intended to reflect a derived total daily dose (EXDOSE multiplied by
 Deprecation of this variable allows exposure dose representation to be in a
single variable (i.e., EXDOSE) and eliminates inconsistent implementations of
the variables across industry.
• (--DOSTOT will be deprecated (phased out) by the next (post v1.4 / v3.1.4)
release )
 Deleted from EX domain table; intended use in the domain was unclear.
 With the addition of the EC domain model and use of FA to represent doses in
alternative units, EXVAMT and EXVAMTU will be deprecated (phased out)
IG 3.1.4 (Batch 1)
Exposure Domains Supplement :
o New domain
EC Definition
a. The Exposure as Collected domain model reflects protocol-specified study treatment
administrations, as-collected.
• EC should be used in all cases where collected exposure information cannot or should
not be directly represented in EX or DA. For example, administrations collected in tablets
but protocol-specified unit is mg, administrations collected in mL but protocol-specified
unit is mg/kg, or administration details are collected as Drug Accountability.
• If EC is an exact duplicate of EX, then EC is not necessary.
• Exposure data are either represented in EX only or EC & EX or DA & EX.
IG 3.1.4 (Batch 1)
Immunogenicity Specimen Assessments (IS) :
The Immunogenicity Specimen Assessments (IS) domain model is used for assessments,
which determines whether a therapy provoked/caused/induced an immune response. For
example, a vaccine is expected to induce an immune response to the therapeutic agent.
Alternatively, a cellular therapy such as Erythropoiesis stimulating agents may induce an
immune response that is not desired.
IG 3.1.4 (Batch 1)
Skin Responses (SR):
The SR domain is a Findings About domain used to submit dermal responses to antigens.
The method of assessment is typically a skin-prick test.
Because a subject is typically exposed to many test materials at the same time. SROBJ is
needed to represent the test material for each response record.
IG 3.1.4 (Batch 1)
Reproductive Details (RD):
o This domain captures all Reproduction details captured in a study related to the subject in
a FINDINGS domain
o Many of the findings proposed originated in legacy data conversions. Any new prospective
reproductive tests need to be proposed with the CDISC Terminology Committee for
formal inclusion
o All medication questions related to Reproduction Details should be mapped to the CM
Interventions domain and categorized accordingly
o The current practice proposed for some Therapeutic Area’s is to populate a subject’s Birth
Control Method in the Subject Characteristics (SC) domain. This was a practice based on
previous SDTM alignment, with no specific Reproduction type domain existing. This finding
should now be populated in the RD Findings domain as RDTESTCD=BCMETHOD and
RDTEST=Birth Control Method to formalize the capture of this data value
Part 2:
Therapeutic Area
Copyright © 2012 Quintiles
Therapeutic Specific Standards
 Virology Draft Standards
This is CDISC’s first attempt to develop submission standards for virology-focused
trials. This document contains 5 proposed new SDTM domains,
which includes basic information gene expression, human genetic variation,
viral genetics and resistance data.
Therapeutic Specific Standards
Parkinson’s Disease Therapeutic Area User Guide
This is a supplement to the SDTM User Guide and will be used with the SDTMIG.
It will guide the user in the organization, structure and format of standard
Parkinson’s disease clinical trial tabulation datasets.
The PD User Guide includes the following in the review package:
• Assumptions and examples for using 10 existing SDTM standard domains
implemented with PD specific common data elements.
•Draft domains and examples for 5 new SDTM draft domains that are
important for PD and are included here to provide context for reviewers.
•Mapping and examples for the core questionnaires, along with their
SDTM annotated CRF’s
Therapeutic Specific Standards
 Pain Therapeutic Area Standards
User Guide,
19 Questionnaire Supplements
13 SDTM Annotated CRFs.
(CT relevant to this PAIN User Guide is being been prepared through the
CDISC Terminology Team and will be released as part of terminology package 12)
Tuberculosis Therapeutic Area User Guide
Includes 4 Draft Domains:
Device in Use (DU)
Morphology (MO)
Microscopic Findings (MI)
Skin Response (SR)
(CT relevant to this TB User Guide is being been prepared through the
CDISC Terminology Team and will be released as part of terminology package 12)
Therapeutic Specific Standards
Alzheimer’s disease/Mild Cognitive Impairment User Guide
• This document comprises version 1.0 of the Alzheimer's disease-specific Therapeutic
Area Supplement User Guide ((SDTMUG-ALZHEIMERS v1.0).
• This guide describes the explicit implementation of a subset of the existing and
new SDTM safety domains.
• The Questionnaires selected for standardization in Alzheimer's disease studies
• The UG describes the assumptions and rules for the SDTM domains,
a data example of specific domains and a SDTM mapping strategy as necessary
The CDISC Questionnaire Terminology Team in the process of assessing copyright
issues and developing controlled terminology for questionnaires. The CDISC website
will be updated on a regular basis to inform you of their progress