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Nutrition studies often require collection of stool samples for analysis. Sample handling events may also be performed on these samples (e.g., freezing the sample). Evaluations (e.g., weight, color) may also be performed on these samples.

Note: Some sponsors may choose to use a validated scale to rate attributes of a stool sample (e.g., Bristol Stool Form Scale). In this case, data would be represented following the QRS supplement. Please refer to Section 6, Questionnaires, Ratings, and Scales, of this TAUG for those scales that have been identified by the Nutrition Team as important for nutrition studies.

Samples are also sent to laboratories for additional analysis. These data are represented in the Laboratory Test Results (LB) domain. At the time of publication, there are no tests that require additional LB examples to be developed in the TAUG-Nutrition; however, the Lab Controlled Terminology team is working to determine whether additional tests may be needed. NUT-61 - Getting issue details... STATUS

Example

This example shows stool sample biospecimen events (i.e., collection, drying, freezing) NUT-62 - Getting issue details... STATUS .

 be.xpt
Rows 1, 3:Show the date and time of the stool sample collection.
Row 2:Shows the date and time of drying the stool sample.
Row 4:Shows the date and time of freezing the stool sample. The container number was represented in BEREFID to identify the sample.

be.xpt

Row

STUDYID

DOMAIN

USUBJID

BESEQ

BEREFID

BETERM

BEDECOD

VISITNUM

VISIT

VISITDY

BEDTC

BESTDTC

BEENDTC

BESTDY


BESPEC
1NUTR123BENUTR123_0011ST123CollectedCOLLECTING1BASELINE-12017-01-03T13:052017-01-03T13:05
-1
STOOL
2NUTR123BENUTR123_0012ST123DryingDRYING1BASELINE-12017-01-03T13:052017-01-03T14:45
-1
STOOL
3NUTR123BENUTR123_0021ST124CollectedCOLLECTING1BASELINE-12017-01-23T15:002017-01-03T15:00
-1
STOOL
4NUTR123BENUTR123_0022ST124FrozenFREEZING1BASELINE-12017-01-23T15:002017-01-23T17:00
-1
STOOL

BE NSV Metadata

In this example, tests were performed on the stool sample (e.g., fresh/dry weight, color, consistency). Note that for each subject in this example, LBLOBXFL=“Y”.  --LOBXFL is not a collected variable, is not inferred from VISIT and VISITNUM, and cannot be populated until after findings and exposure data are  collected.  --LOBXFL=“Y” means that, for this subject, this record was the last record with a non-missing result for this test prior to DM.RFXSTDTC (the date/time of subject's first exposure in EX). NUT-29 - Getting issue details... STATUS NUT-63 - Getting issue details... STATUS
 lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBSEQ

LBREFID

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESU

LBSTRESC

LBSTRESN

LBSTRESU

LBSPEC

LBSPCCND

LBLOBXFL

VISITNUM

VISIT

VISITDY

LBDTC

1NUTR123LBNUTR123_0011ST123SPWEIGHTSpecimen WeightSPECIMEN ASSESSMENT95g9595gSTOOLFRESHY-1Baseline-12017-01-03T13:10
2NUTR123LBNUTR123_0012ST123COLORColorSPECIMEN ASSESSMENTBrown
BROWN

STOOLFRESHY-1Baseline-12017-01-03T13:10
3NUTR123LBNUTR123_0013ST123CONSISTConsistencySPECIMEN ASSESSMENTSoft
SOFT

STOOLFRESHY-1Baseline-12017-01-03T13:10
4NUTR123LBNUTR123_0014ST123SPWEIGHTSpecimen WeightSPECIMEN ASSESSMENT20g2020gSTOOLDRIEDY-1Baseline-12017-01-03T13:10
The relrec.xpt example reflects a many-to-many dataset-level relationship between BE and LB using --REFID. NUT-64 - Getting issue details... STATUS
 relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1NUTR123BE
BEREFID
MANY1
2NUTR123LB
LBREFID
MANY1

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