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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 Representing Relationships and Data
8.4 Relating Non-Standard Variables Values to a Parent Domain
8.4.4 Alternative Representation of Non-Standard Variables
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:
- Non-Standard Identifier
- Non-Standard Qualifier
- 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 | |
HOAERPFLAERPFL | AE Reported This Episode? |
HOMEDSFLMEDSFL | Meds Prescribed? |
HOPROCFLPROCFL | Procedures Performed? |
HOPROVNMPROVNM | Provider Name |
HOSPUFLSPUFL | Any Time in Spec. Unit? |
HOSPUTYPSPUTYP | Specialized Unit Type |
HORLCNDFRLCNDF | 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.
Localtab Group | ||||
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ho.xpt: Healthcare Encounters
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 |
suppho.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
---|---|---|---|---|---|---|---|---|---|---|
1 | 1999001 | HO | 0001 | HOSEQ | 1 | HOAERPFL | AE Reported This Episode | Y | CRF |
|
2 | 1999001 | HO | 0001 | HOSEQ | 1 | HOMEDSFL | Meds Prescribed | Y | CRF |
|
3 | 1999001 | HO | 0001 | HOSEQ | 1 | HOPROCFL | Procedures Performed | Y | CRF |
|
4 | 1999001 | HO | 0001 | HOSEQ | 1 | HOPROVNM | Provider Name | General Hosp | CRF |
|
5 | 1999001 | HO | 0001 | HOSEQ | 1 | HOSPUFL | Specialized Unit Type | ICU | CRF |
|
6 | 1999001 | HO | 0001 | HOSEQ | 1 | HOSPUTYP | Any Time in Spec. Unit | Y | CRF |
|
7 | 1999001 | HO | 0001 | HOSEQ | 1 | HORLCNDF | Visit Related to Study Med Cond. | Y | CRF |
|
8 | 1999001 | HO | 0001 | HOSEQ | 2 | HOAERPFL | AE Reported This Episode | Y | CRF |
|
9 | 1999001 | HO | 0001 | HOSEQ | 2 | HOMEDSFL | Meds Prescribed | Y | CRF |
|
10 | 1999001 | HO | 0001 | HOSEQ | 2 | HOPROCFL | Procedures Performed | N | CRF |
|
11 | 1999001 | HO | 0001 | HOSEQ | 2 | HOPROVNM | Provider Name | Univ Hosp | CRF |
|
12 | 1999001 | HO | 0001 | HOSEQ | 2 | HOSPUFL | Specialized Unit Type | CCU | CRF |
|
13 | 1999001 | HO | 0001 | HOSEQ | 2 | HOSPUTYP | Any Time in Spec. Unit | Y | CRF |
|
14 | 1999001 | HO | 0001 | HOSEQ | 2 | HORLCNDF | Visit Related to Study Med Cond. | Y | CRF |
|
15 | 1999001 | HO | 0002 | HOSEQ | 1 | HOAERPFL | AE Reported This Episode | Y | CRF |
|
16 | 1999001 | HO | 0002 | HOSEQ | 1 | HOMEDSFL | Meds Prescribed | N | CRF |
|
17 | 1999001 | HO | 0002 | HOSEQ | 1 | HOPROCFL | Procedures Performed | Y | CRF |
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18 | 1999001 | HO | 0002 | HOSEQ | 1 | HOPROVNM | Provider Name | St. Mary's | CRF |
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19 | 1999001 | HO | 0002 | HOSEQ | 1 | HOSPUFL | Specialized Unit Type | ICU | CRF |
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20 | 1999001 | HO | 0002 | HOSEQ | 1 | HOSPUTYP | Any Time in Spec. Unit | N | CRF |
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21 | 1999001 | HO | 0002 | HOSEQ | 1 | HORLCNDF | Visit Related to Study Med Cond. | Y | CRF |
|
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ho.xpt: Healthcare Encounters
Row | STUDYID | DOMAIN | USUBJID | HOSEQ | HOTERM | HOSTDTC | HOENDTC | HODUR |
| HOAERPFL | HOMEDSFL |
1 | 1999001 | HO | 0001 | 1 | Hospital | 2004-01-05 | 2004-01-12 | P1W |
| Y | Y |
2 | 1999001 | HO | 0001 | 2 | Hospital | 2004-01-23 | 2004-02-07 | P15D |
| Y | Y |
3 | 1999001 | HO | 0002 | 1 | Hospital | 2004-01-21 | 2004-01-22 | P1D |
| Y | N |
Row | HOMEDSFL | HOPROCFL | HOPROVNM | HOSPUFL | HOSPUTYP | HORLCNDF |
1 (cont) | Y | Y | General Hosp | ICU | Y | Y |
2 (cont) | Y | N | Univ Hosp | CCU | Y | Y |
3 (cont) | N | Y | St. Mary's | ICU | N | Y |
HO NSV Metadata
Variable Name
Variable Label
Type
Controlled Terms,
Codelist, or Format
Origin
Role
Evaluator
Comments
HOAERPFL
AE Reported This Episode
Char
No Yes Response
CRF
Non-Standard Qualifier
HOMEDSFL
Meds Prescribed
Char
No Yes Response
CRF
Non-Standard Qualifier
HOPROCFL
Procedures Performed
Char
No Yes Response
CRF
Non-Standard Qualifier
HOPROVNM
Provider Name
Char
CRF
Non-Standard Qualifier
HOSPUFL
Specialized Unit Type
Char
CRF
Non-Standard Qualifier
HOSPUTYP
Any Time in Spec. Unit
Char
No Yes Response
CRF
Non-Standard Qualifier
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HORLCNDF
Visit Related to Study Med Cond.
Char
No Yes Response
CRF
Non-Standard Qualifier
8.4.5 When Not to Use Non-Standard Variables
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This section is identical to Section 8.4.4 in SDTMIG v3.2. |
Examples of data that should not be submitted as Supplemental Qualifiers are the following:
- Subject-level objective data that fit in Subject Characteristics (SC). Examples include Marital Status, Skin Classification, Education Level.
- Findings interpretations that should be added as an additional test code and result. An example of this would be a record for ECG interpretation where EGTESTCD = “INTP”, and the same EGGRPID or EGREFID value would be assigned for all records associated with that ECG (see Section 4: 4.1.5.5, Clinical Significance For Findings Observation Class Data).
- Comments related to a record or records contained within a parent dataset. Although they may have been collected in the same record by the sponsor, comments should instead be captured in the CO special-purpose domain.
- Data not directly related to records in a parent domain. Such records should instead be captured in either a separate general observation class or special purpose domain.