suppqual – where’s my mommy? sandra vanpelt nguyen midwest cdisc users group may 2012
TRANSCRIPT
SUPPQUAL – Where’s My Mommy?
Sandra VanPelt NguyenMidwest 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
© 2011. All rights reserved. 6
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
CMTRT
CMSTDTC
CMENDTC
CMLOC
CMDOSE/CMDOSTXT
CMDOSU
SUPPQUAL Example: Parent-Child Relationship
USUBJID CMSEQ CMTRT CMDOSE CMDOSU CMLOC CMSTDTC CMENDTC
ABC-001-0001 1 PALLIATIVE RADIATION 68 Gy PROSTATE 2010-01-20 2010-03-01
CM:
SUPPCM:
USUBJID RDOMAIN IDVAR IDVARVAL QNAM QLABEL QVAL
ABC-001-0001 CM CMSEQ 1 REASDISC Reason for Discontinuation Completed therapy
SUPPQUAL Example: No Parent
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
CM:
SUPPCM:
USUBJID RDOMAIN IDVAR IDVARVAL QNAM QLABEL QVAL
ABC-001-0001 CM CMSEQ 2 REASDISC Reason for Discontinuation Completed therapy
NO MATCH ON USUBJID, CMSEQ
SD0078: Referenced record not found
SUPPQUAL Example: No Parent
SUPPCM:
USUBJID RDOMAIN IDVAR IDVARVAL QNAM QLABEL QVAL
ABC-001-0001 CM REASDISC Reason for Discontinuation Completed therapy
What to do when you do not know what to use for IDVAR/IDVARVAL?
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 in a general observation
class domain?
(2) Is there a not-so-obvious parent?
(3) Is the data actually needed?Time to get creative!
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) Does the data belong in a general observation
class domain?
(2) Is there a not-so-obvious parent?
Applying the Guidelines – Example 3
Applying the Guidelines – Example 4
(2) Is there a not-so-obvious parent?
(1) Does the data belong in a general observation
class domain?
Applying the Guidelines – Example 5
(2) Is there a not-so-obvious parent?
(1) Does the data belong in a general observation
class domain?
(3) Is the data actually needed?
Applying the Guidelines – Example 5
Applying the Guidelines – Example 6
(3) Is the data actually needed?
Time to get creative!(1) Does the data belong in a general observation
class domain?
(2) Is there a not-so-obvious parent?
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.
