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This is the Wiki edition of the proposed SDTMIG Relationships section entitled "Alternative Representation of Non-Standard Variables", also called the "NSV Proposal". It went to public review as part of Batch 2 for SDTMIG v3.3.

This draft section is intended to be inserted into SDTMIG v3.3 Section 8, before the section entitled "When Not to Use Non-Standard Variables", which is Section 8.4.4 in SDTMIG v3.2, but would become Section 8.4.5 in SDTMIG v3.3.

8.4.4.1   Background

As an alternative to submitting non-standard variables (NSVs) in separate SUPP-- datasets, they may be represented in the parent datasets. This method provides some additional benefits. These include the following:

  • Permitting direct viewing of standard variables and NSVs within the same structure, eliminating the need for tools or the writing of programs to display the data together.
  • Eliminating some current SUPP-- structural limitations by allowing:
    • Numeric NSVs to be represented in a numeric data type
    • Character NSVs to be defined with an appropriate length for each variable, rather than the typical default of $200 for QVAL
    • Allowing metadata for NSVs (including Controlled Terminology) to be applied at the variable level instead of the value-level.

8.4.4.2   Implementation Rules

In order to use the alternative described above, the following implementation rules must be followed:

  • The list domains to which NSVs may be added does not change. NSVs may be added only to general-observation-class domains and Demographics.
  • The same considerations must be used in assessing the number of NSVs represented, regardless of whether they are represented in SUPP-- datasets or in the parent domains. In other words, sponsors must not seek this implementation as a method for representing NSVs that would not have previously been represented in SUPP-- datasets.
  • Complete metadata must be provided for each NSV in the same way it’s required for standard variables.
  • Variable lengths for character NSVs should be set to the appropriate length for that variable, as with all standard character variables.
  • Metadata roles for NSVs are defined appropriately, based upon the SDTM variables roles, and must be one of the following Roles:
    1. Non-Standard Identifier
    2. Non-Standard Qualifier, further categorizable into:
      • Non-Standard Grouping Qualifier
      • Non-Standard Result Qualifier
      • Non-Standard Synonym Qualifier
      • Non-Standard Record Qualifier
      • Non-Standard Variable Qualifier
    3. Non-Standard Timing
  • NSVs would be ordered after the standard variables, and ordered as shown in the bullet above. The order within each of the non-standard Roles should be consistent within the dataset and the define.xml.

Example

This is an example of hospitalization data with non-standard variables.

This example shows three hospitalization records, two for Subject 0001, and one for Subject 0002. In the collected data, there are standard variables from the SDTM: Identifiers from Table 2.2.4, Event Qualifiers from Table 2.2.2 of the SDTM, Timing variables from Table 2.2.5. In addition, there are the following non-standard variables:

Non-Standard Variables

AERPFL

AE Reported This Episode?

MEDSFL

Meds Prescribed?

PROCFL

Procedures Performed?

PROVNM

Provider Name

SPUFL

Any Time in Spec. Unit?

SPUTYP

Specialized Unit Type

RLCNDF

Visit Related to Study Med Cond.?

Two methods are shown for the representation and submission of these data: the method of submitting NSVs in SUPPHO and the new method of submitting NSVs in the parent domain.

.

ho.xpt

Row

STUDYID

DOMAIN

USUBJID

HOSEQ

HOTERM

HOSTDTC

HOENDTC

HODUR

1

1999001

HO

0001

1

Hospital

2004-01-05

2004-01-12

P1W

2

1999001

HO

0001

2

Hospital

2004-01-23

2004-02-07

P15D

3

1999001

HO

0002

1

Hospital

2004-01-21

2004-01-22

P1D

$warningHtml

suppho.xpt

$titleHtml

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

QNAM

QLABEL

QVAL

QORIG

QEVAL

1

1999001

HO

0001

HOSEQ

1

AERPFL

AE Reported This Episode

Y

CRF


2

1999001

HO

0001

HOSEQ

1

MEDSFL

Meds Prescribed

Y

CRF


3

1999001

HO

0001

HOSEQ

1

PROCFL

Procedures Performed

Y

CRF


4

1999001

HO

0001

HOSEQ

1

PROVNM

Provider Name

General Hosp

CRF


5

1999001

HO

0001

HOSEQ

1

SPUFL

Specialized Unit Type

ICU

CRF


6

1999001

HO

0001

HOSEQ

1

SPUTYP

Any Time in Spec. Unit

Y

CRF


7

1999001

HO

0001

HOSEQ

1

RLCNDF

Visit Related to Study Med Cond.

Y

CRF


8

1999001

HO

0001

HOSEQ

2

AERPFL

AE Reported This Episode

Y

CRF


9

1999001

HO

0001

HOSEQ

2

MEDSFL

Meds Prescribed

Y

CRF


10

1999001

HO

0001

HOSEQ

2

PROCFL

Procedures Performed

N

CRF


11

1999001

HO

0001

HOSEQ

2

PROVNM

Provider Name

Univ Hosp

CRF


12

1999001

HO

0001

HOSEQ

2

SPUFL

Specialized Unit Type

CCU

CRF


13

1999001

HO

0001

HOSEQ

2

SPUTYP

Any Time in Spec. Unit

Y

CRF


14

1999001

HO

0001

HOSEQ

2

RLCNDF

Visit Related to Study Med Cond.

Y

CRF


15

1999001

HO

0002

HOSEQ

1

AERPFL

AE Reported This Episode

Y

CRF


16

1999001

HO

0002

HOSEQ

1

MEDSFL

Meds Prescribed

N

CRF


17

1999001

HO

0002

HOSEQ

1

PROCFL

Procedures Performed

Y

CRF


18

1999001

HO

0002

HOSEQ

1

PROVNM

Provider Name

St. Mary's

CRF


19

1999001

HO

0002

HOSEQ

1

SPUFL

Specialized Unit Type

ICU

CRF


20

1999001

HO

0002

HOSEQ

1

SPUTYP

Any Time in Spec. Unit

N

CRF


21

1999001

HO

0002

HOSEQ

1

RLCNDF

Visit Related to Study Med Cond.

Y

CRF


$warningHtml

ho.xpt

RowSTUDYIDDOMAINUSUBJIDHOSEQHOTERMHOSTDTCHOENDTCHODUR
AERPFLMEDSFLPROCFLPROVNMSPUFLSPUTYPRLCNDF
11999001HO00011Hospital2004-01-052004-01-12P1W
YYYGeneral HospICUYY
21999001HO00012Hospital2004-01-232004-02-07P15D
YYNUniv HospCCUYY
31999001HO00021Hospital2004-01-212004-01-22P1D
YNYSt. Mary'sICUNY
$warningHtml

HO NSV Metadata

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