Transcript Sample title slide 32 pt Arial

SUPPQUAL – Where’s My Mommy?
Sandra VanPelt Nguyen
Midwest CDISC Users Group May 2012
Abstract
When using CDISC standards, there may be situations in which a
field has been collected on a CRF or included in a vendor data
transfer which seems to be clinically relevant but is not “topic”
data belonging in a standard or custom SDTM domain (any of the
three general observation classes). Since non-standard variables
cannot be added to SDTM domains, this data typically gets
mapped to a SUPPQUAL (Supplemental Qualifiers) dataset, but
what do we do when there is not an obvious “parent” record
corresponding to this data within one of the SDTM domains? This
presentation will provide a set of guidelines to use to determine
how best to handle these situations.
Discussion Topics
► Introduction/Background
► Guidelines
► Examples
© 2011. All rights reserved.
3
Intro to Supplemental Qualifiers (SUPPQUAL)
► CDISC SDTM organizes data in domains (datasets) based on topic
► Topics are divided amongst 3 general domain classes - Interventions, Events,
Findings
► Topics which do not fall into a reserved SDTM domain but fit into a general
domain class may go into custom domains
► Variables cannot be added to domains with exception of certain timing, identifier
and qualifier variables allowable within the general domain class
► SDTM allows for the inclusion of additional variables using the Supplemental
Qualifiers special-purpose domain
Intro to Supplemental Qualifiers (SUPPQUAL)
► SUPPQUAL is used to capture non-standard variables and their association to
parent records in general observation class datasets or DM (demographics)
► QNAM (qualifier variable name) and QLABEL (qualifier variable label) are used to
describe the particular qualifier
► Variables IDVAR (identifying variable) and IDVARVAL (identifying variable value)
provide the linkage between records (qualifier child to observation(s) parent) by
identifying the variable to join on and the variable value of the specific record(s)
which are related
► SUPPQUAL is typically split as SUPP--, with the suffix based on the related
domain’s code, e.g. SUPPAE for qualifiers related to the AE domain
SUPPQUAL Example
CMTRT
CMTRT
Reported Name of Drug, Med, or
Therapy
CMCAT
Category for Medication
CMINDC
Indication
CMDOSE
Dose per Administration
CMDOSTXT
Dose Description
CMDOSU
Dose Units
CMSTDTC
Start Date/Time of Medication
CMENDTC
End Date/Time of Medication
CMLOC
Location of Dose Administration
CMSTDTC
CMENDTC
CMLOC
CMDOSE/CMDOSTXT
CMDOSU
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SUPPQUAL Example: Parent-Child Relationship
CM:
USUBJID
CMSEQ
CMTRT
CMDOSE
CMDOSU
CMLOC
CMSTDTC
CMENDTC
ABC-001-0001
1
PALLIATIVE RADIATION
68
Gy
PROSTATE
2010-01-20
2010-03-01
SUPPCM:
USUBJID
RDOMAIN
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
ABC-001-0001
CM
CMSEQ
1
REASDISC
Reason for Discontinuation
Completed therapy
SUPPQUAL Example: No Parent
CM:
USUBJID
CMSEQ
CMTRT
CMDOSE
CMDOSU
CMLOC
CMSTDTC
CMENDTC
ABC-001-0001
1
PALLIATIVE RADIATION
68
Gy
PROSTATE
2010-01-20
2010-03-01
ABC-001-0002
1
PALLIATIVE RADIATION
72
Gy
PROSTATE
2010-11-01
2010-11-25
NO MATCH ON
USUBJID, CMSEQ
SUPPCM:
USUBJID
RDOMAIN
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
ABC-001-0001
CM
CMSEQ
2
REASDISC
Reason for Discontinuation
Completed therapy
SD0078: Referenced record not found
SUPPQUAL Example: No Parent
SUPPCM:
What to do when you do not
know what to use for
IDVAR/IDVARVAL?
USUBJID
RDOMAIN
ABC-001-0001
CM
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
REASDISC
Reason for Discontinuation
Completed therapy
Sample CRF
Mapping Guidelines
1. Does the data belong in a general observation class
domain?
2. Is there a not-so-obvious parent?
3. Is the data actually needed?
4. Time to get creative
Applying the Guidelines – Example 1
(1) Does the data belong
(3)
(2)IsIsthe
there
data
a not-soactually
in Time
a general
observation
to getparent?
creative!
obvious
needed?
class domain?
Applying the Guidelines – Example 1
Applying the Guidelines – Example 2
(1) Does the data belong
in a general observation
class domain?
Applying the Guidelines – Example 2
Applying the Guidelines – Example 3
(1)(2)
Does
the data
belong
Is there
a not-soin a obvious
general observation
parent?
class domain?
Applying the Guidelines – Example 3
Applying the Guidelines – Example 4
(1)(2)
Does
the data
belong
Is there
a not-soin a obvious
general observation
parent?
class domain?
Applying the Guidelines – Example 5
(1)
(3)Does
(2)
Is the
Isthe
there
data
data
actually
a not-sobelong
in a general
obvious
needed?
observation
parent?
class domain?
Applying the Guidelines – Example 5
Applying the Guidelines – Example 6
getdata
creative!
(1)Time
Doestothe
belong
(3) (2)
Is the
Is there
data actually
a not-soin a general observation
obvious
needed?
parent?
class domain?
Applying the Guidelines – Example 6
Conclusion
► Be on the lookout for possible “lost children” when annotating and
creating mapping specifications.
► Be mindful of the intent and relevance of the data.
► Consider how/if the information will be used for review or analysis.
► Determine the best fit within the SDTM standard.
Thank you
Sandra VanPelt Nguyen
[email protected]
© 2011. All rights reserved.
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