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Patient diaries can be used to collect information on number of stools and consistency on a daily basis. In this case, the calculation of average number of stools or the typical consistency over the 3-day period may be calculated in an ADaM dataset from this source data.

Example

This example shows baseline stool information for actual daily number of bowel movements and typical stool consistency each day over a 3-day period prior to the baseline visit. Please note that it may be important for sponsors to provide additional instructions to the diary (e.g., how a subject should evaluate their consistency if they had 1 loose and 1 hard stool in a day).

The sponsor chose to use a paper diary that was given to subject prior to the visit and then handed back at the visit where this was entered into the EDC system.

FAOBJ Hidden/pre-populated
BOWEL MOVEMENT
FAEVLINT FAEVLINT and LBEVLINT Hidden/pre-populated
-P1D
Select the diary day being entered. What is the diary day?
FATPT FATPT and LBTPT
Record the date the subject indicated the diary was completed.
FADAT FADTC and LBDTC
_________________
Record the number of bowel movements that the subject had on this day.
EPSDNUM_FAORRES FAORRES where FATESTCD = "EPSDNUM"
_________________
LBSPEC Hidden/pre-populated
STOOL
Record the typical consistency of the subject's stools over this day. What is the typical consistency of bowel movements as reported by the subject?
CONSIST_LBORRES LBORRES where LBTESTCD = "CONSIST"
CONSIST_LBCOLSRT NSV.LBCOLSRT where LBTESTCD = "CONSIST" Hidden/pre-populated
TYPICAL
 View CRF Metadata

Columns whose headers are shaded blue and rows whose Field ID are shaded blue contain metadata that were developed for this example annotated CRF, and are not part of the CDASH model or CDASHIG.

Observation ClassOrder Number Domain TAUG ReferenceCDASH Variable NameCDASHIG Variable Label  Question TextPromptField TypeCase Report Form Completion InstructionsInformation for SponsorsTA Specific Usage RulesSDTMIG TargetSDTM Variable Mapping Controlled Terminology CodeList NamePre-Defined ValuesValue that appears on the CRF but is not entered by the user DIsplayed QueryHidden?
Findings01FATAUG-NUT v1.0-Baseline Information on bowel movementsFAOBJFinding About ObjectN/AN/AtextN/AN/A
FAOBJ
N/A
BOWEL MOVEMENT
hidden
Findings02FATAUG-NUT v1.0-Baseline Information on bowel movementsFAEVLINTEvaluation IntervalN/AN/AtextN/AN/A
FAEVLINT and LBEVLINT
N/A
-P1D
hidden
Findings03FATAUG-NUT v1.0-Baseline Information on bowel movementsFATPTPlanned Time Point NameWhat is the diary day?Diary DaytextSelect the diary day being entered.N/A
FATPT and LBTPT
N/AEND OF DIARY DAY -3;END OF DIARY DAY -2;END OF DIARY DAY -1


Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsFADATDate of CollectionWhat is the diary date?Diary DatetextRecord the date the subject indicated the diary was completed.N/A
FADTC and LBDTC





Findings05FATAUG-NUT v1.0-Baseline Information on bowel movements EPSDNUM_FAORRESFindings About ResultWhat is the number of bowel movements reported by the subject?Number of bowel movementstextRecord the number of bowel movements that the subject had on this day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM
FAORRES FAORRES where FATESTCD = "EPSDNUM"N/A



Findings06LBTAUG-NUT v1.0-Baseline Information on bowel movementsLBSPECSpecimen TypeN/AN/AtextN/AN/A
LBSPEC
N/A
STOOL
hidden
Findings07LBTAUG-NUT v1.0-Baseline Information on bowel movements CONSIST_LBORRESFindings About ResultWhat is the typical consistency of bowel movements as reported by the subject?Typical bowel movement consistencytextRecord the typical consistency of the subject's stools over this day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM
LBORRES LBORRES where LBTESTCD = "CONSIST"N/AWatery;Loose;Soft;Formed;Hard


Findings08LBTAUG-NUT v1.0-Baseline Information on bowel movementsCONSIST_LBCOLSRTCollected Summary Result TypeN/AN/Atext
An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM
NSV.LBCOLSRT NSV.LBCOLSRT where LBTESTCD = "CONSIST"N/A
TYPICAL
hidden
See Section 1.3, CDASH Metadata and Annotated CRFs, for explanation of annotations.

Because this data is based on a diary, NUT-89 - Getting issue details... STATUS the sponsor chose to leave the variable VISITNUM blank as these assessments are not completed at a specified protocol visit. 

The total daily number of bowel movements for each of the 3 days of the diary is represented in the FACE domain.

 face.xpt

face.xpt

Row

STUDYID

DOMAIN

USUBJID

FASEQ

FAREFID

FASPID

FATESTCD

FATEST

FAOBJ

FAORRES

FAORRESU

FASTRESC

FASTRESNFASTRESUFAEVAL

VISITNUM

FADTC

FATPTFATPTNUMFAEVLINT
1NUTR123FANUTR123_0011D-3_11EVENTFRQ

Event Frequency

BOWEL MOVEMENT2/day 22/daySUBJECT
2017-01-02END OF DIARY DAY -3-3-P1D
2NUTR123FANUTR123_0012D-2_12EVENTFRQEvent FrequencyBOWEL MOVEMENT3/day33/daySUBJECT
2017-01-03END OF DIARY DAY -2-2-P1D
3NUTR123FANUTR123_0013D-1_13EVENTFRQEvent FrequencyBOWEL MOVEMENT2/day22/daySUBJECT
2017-01-04END OF DIARY DAY -1-1-P1D
The typical stool consistency bowel movements for each of the 3 days of the diary  is represented in the LB domain. The consistency of the stool was assessed by the subject at the end of the day therefore LBEVAL was used to represent this. If a caregiver was assessing the stool sample (e.g., for an infant) then LBEVAL would be "CAREGIVER."
 lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBSEQ

LBREFID

LBSPID

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESULBORNRLOLBORNRHI

LBSTRESC

LBSTRESNLBSTRESULBSTNRLOLBSTNRHILBSTREFCLBNRINDLBSPECLBEVALLBLOBXFL

VISITNUM

LBDTC

LBTPTLBTPTNUMLBEVLINT
LBCOLSRT
1NUTR123LBNUTR123_0011D-3_11CONSISTConsistency
Loose


Loose





STOOLSUBJECT

2017-01-02END OF DIARY DAY -3-3-P1D
TYPICAL
2NUTR123LBNUTR123_0012D-2_12CONSISTConsistency
Hard


Hard





STOOLSUBJECT

2017-01-03END OF DIARY DAY -3-2-P1D
TYPICAL
3NUTR123LBNUTR123_0013D-1_13CONSISTConsistency
Loose


Loose





STOOLSUBJECT

2017-01-04END OF DIARY DAY -3-1-P1D
TYPICAL

LB NSV Metadata

The relrec.xpt example is represented below.
 relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1NUTR123FA
FAREFID
ONE1
2NUTR123LB
LBREFID
MANY1

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