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In some cases patient diaries can also be used to collect information on individual stool episodes and consistency within each day. 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 each bowel movement and the corresponding stool consistency for each stool episode over a 3-day period prior to the baseline visit. 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.

CETERM Hidden/pre-populated
BOWEL MOVEMENT
Select the diary day being entered What is the diary day?
CETPT CETPT and LBTPT
Record the date the subject indicated the diary was completed
CESTDAT CEDTC and CESTDTC and LBDTC
_________________
CEPRESP Hidden/pre-populated
Y
Indicate if any bowel movements occurred, checking Yes or No. Did the subject have any bowel movements for this day?
CEOCCUR
Record the bowel movement episode number. For each diary day, start the count at 1. What is the clinical event identifier?
CESPID CESPID and LBSPID
Record the start time the subject indicated the bowel movement started
CESTTIM CESTDTC LBDTC
_________________
LBSPEC Hidden/pre-populated
STOOL
Record the consistency of the subject's stool What is the consistency of bowel movement reported by the subject?
CONSIST_LBORRES LBORRES where LBTESTCD = "CONSIST"
Record the color of the subject's stool What is the color of bowel movement reported by the subject?
COLOR_LBORRES LBORRES where FATESTCD = "COLOR"
 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 MappingControlled Terminology CodeList NamePre-Defined ValuesValue that appears on the CRF but is not entered by the user DIsplayed QueryHidden?
Findings01CETAUG-NUT v1.0-Baseline Information on bowel movementsCETERMClinical Event Reported TermN/AN/AtextN/A

CETERMCETERMN/A
BOWEL MOVEMENT
Hidden
Findings02CETAUG-NUT v1.0-Baseline Information on bowel movementsCETPTPlanned Time Point NameWhat is the diary day?Diary DaytextSelect the diary day being entered

CETPTCETPT and LBTPTN/ADIARY DAY -3;DIARY DAY -2;DIARY DAY -1


Findings03FATAUG-NUT v1.0-Baseline Information on bowel movementsCESTDATClinical Event Start DateWhat is the diary date?Diary DatetextRecord the date the subject indicated the diary was completedThis date is used to populate CEDTC. It is then combined with the Start Time of the bowel movement to create CESTDTC and FADTC .
CESTDTCCEDTC and CESTDTC and LBDTC




Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsCEPRESPClinical Event Pre-SpecifiedN/AN/Atext


CEPRESP


Y
Hidden
Findings05FATAUG-NUT v1.0-Baseline Information on bowel movementsCEOCCURClinical Event OccurrenceDid the subject have any bowel movements for this day?Bowel MovementstextIndicate if any bowel movements occurred, checking Yes or No.

CEOCCUR

Yes; No


Findings06FATAUG-NUT v1.0-Baseline Information on bowel movementsCESPIDClinical Event Sponsor-Defined IdentifierWhat is the clinical event identifier?Bowel Movement NumbertextRecord the bowel movement episode number. For each diary day, start the count at 1.

CESPIDCESPID and LBSPIDN/A1; 2; 3; 4; 5; 6; 7; 8; 9; 10


Findings07FATAUG-NUT v1.0-Baseline Information on bowel movementsCESTTIMStart Time of Clinical EventWhat was the bowel movement start time?Start Time of the bowel movementtextRecord the start time the subject indicated the bowel movement startedThis date is used to populate CEDTC. It is then combined with the Start Time of the bowel movement to create CESTDTC and FADTC .
CESTDTCCESTDTC LBDTC




Findings08LBTAUG-NUT v1.0-Baseline Information on bowel movementsLBSPEC
Specimen TypeN/AtextN/A

LBSPEC
N/A
STOOL
Hidden
Findings09LBTAUG-NUT v1.0-Baseline Information on bowel movements CONSIST_LBORRES
What is the consistency of bowel movement reported by the subject?Bowel movement consistencytextRecord the consistency of the subject's stoolAn example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
LBORRESLBORRES where LBTESTCD = "CONSIST"N/AWatery; Loose; Soft; Formed; Hard


Findings10LBTAUG-NUT v1.0-Baseline Information on bowel movementsCOLOR_LBORRES
What is the color of bowel movement reported by the subject?Bowel movement colortextRecord the color of the subject's stoolAn example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
LBORRESLBORRES where FATESTCD = "COLOR"N/AYellow; Green; Brown; Black


See Section 1.3, CDASH Metadata and Annotated CRFs, for explanation of annotations.


  • Because these data are based on a diary, the sponsor chose to leave the variables VISITNUM blank as these assessments are not completed at a specified protocol visit.
  • Because data were collected on individual bowel movement episodes, these were considered clinical events and therefore data for the occurrence of each episode were represented in the CE domain.
  • The consistency and color of each episode were represented in the Laboratory Findings (LB) domain.
  • Because the sponsor instructed the subject to record the time equivalent to the start of the bowel movement, CESTDTC was used to represent the start date and time of the bowel movement.
  • CEREFID was populated by the sponsor to represent the diary day number and the individual bowel movement (e,g,. D-3_1 represents bowel movement 1 on diary Day -3). The same format was used for LBREFID showing the consistency and color of the stool nut NUT-141 - Getting issue details... STATUS . The CE and LB datasets can therefore be linked based on --REFID variables.
  • The rows are color coded to help identify each day of the diary.

 ce.xpt
Rows 1-3:Show 3 bowel movement episodes on the first day of the diary.
Rows 4-5:Show 2 bowel movement episodes on the second day of the diary.
Rows 6-7:Show 2 bowel movement episodes on the third day of the diary.
Row 8:Shows an example of where there are no bowel movements episodes for the first day of the diary (although this is quite unlikely).
Row 9:Shows an example of where the subject forgot to record any bowel movement episodes for the second day of the diary. In this example, there was just a line struck through the diary with a note of "Forgot to complete." As no other data was recorded by the subject, CEDTC/CESTDTC/CEOCCUR are all blank. The CESTAT and CEREASND variables are used to show that the bowel movement assessments were not done on this day.

ce.xpt

Row

STUDYID

DOMAIN

USUBJID

CESEQ

CEREFIDCESPID

CETERM

CEPRESPCEOCCURCESTATCEREASNDCEDTC

CESTDTC

CETPTCETPTNUM
1NUTR123CENUTR123_0011D-3_11BOWEL MOVEMENTYY

2017-01-022017-01-02 T09:45DIARY DAY -3-3
2NUTR123CENUTR123_0012D-3_22BOWEL MOVEMENTYY

2017-01-022017-01-02 T12:45DIARY DAY -3-3
3NUTR123CENUTR123_0013D-3_33BOWEL MOVEMENTYY

2017-01-022017-01-02 T19:45DIARY DAY -3-3
4NUTR123CENUTR123_0014D-2_11BOWEL MOVEMENTYY

2017-01-032017-01-03 T08:30DIARY DAY -2-2
5NUTR123CENUTR123_0015D-2_22BOWEL MOVEMENTYY

2017-01-032017-01-03 T20:00DIARY DAY -2-2
6NUTR123CENUTR123_0016D-1_11BOWEL MOVEMENTYY

2017-01-042017-01-04 T09:00DIARY DAY -1-1
7NUTR123CENUTR123_0017D-1_22BOWEL MOVEMENTYY

2017-01-042017-01-04 T21:00DIARY DAY -1-1
8NUTR123CENUTR123_0021D-3_11BOWEL MOVEMENTYN

2017-02-12
DIARY DAY -3-3
9NUTR123CENUTR123_0022D-2_11BOWEL MOVEMENTY
NOT DONEFORGOT TO COMPLETE

DIARY DAY -2-2
The following example shows the consistency and color of each stool episode from the CE data above. Note that there is no LB consistency/color data for the last 2 rows of the CE dataset above, because they represent (1) a day when there were no bowel movement episodes and (2) a day when the subject forgot to complete the diary. The consistency of the stool was assessed by the infant's caregiver and therefore LBEVAL was used to represent this. If a subject was assessing their own stool sample then LBEVAL would be "SUBJECT."
 lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBSEQ

LBREFID

LBSPID

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESULBORNRLOLBORNRHI

LBSTRESC

LBSTRESNLBSTRESULBSTNRLOLBSTNRHILBSTREFCLBNRINDLBSPECLBEVALLBLOBXFL

VISITNUM

LBDTC

LBTPTLBTPTNUM
1NUTR123LBNUTR123_0011D-3_11CONSISTConsistency
Loose


Loose





STOOLCAREGIVER

2017-01-02 T09:45DIARY DAY -3-3
2NUTR123LBNUTR123_0012D-3_11COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-02 T09:45DIARY DAY -3-3
3NUTR123LBNUTR123_0013D-3_22CONSIST
Consistency
Hard


Hard





STOOLCAREGIVER

2017-01-02 T12:45DIARY DAY -3-3
4NUTR123LBNUTR123_0014D-3_22COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-02 T12:45DIARY DAY -3-3
5NUTR123LBNUTR123_0015D-3_33CONSIST
Consistency
Loose


Loose





STOOLCAREGIVER

2017-01-02 T19:45DIARY DAY -3-3
6NUTR123LBNUTR123_0016D-3_33COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-02 T19:45DIARY DAY -3-3
7NUTR123LBNUTR123_0017D-2_11CONSIST
Consistency
Hard


Hard





STOOLCAREGIVER

2017-01-03 T08:30DIARY DAY -2-2
8NUTR123LBNUTR123_0018D-2_11COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-03 T08:30DIARY DAY -2-2
9NUTR123LBNUTR123_0019D-2_22CONSIST
Consistency
Hard


Hard





STOOLCAREGIVER

2017-01-03 T20:00DIARY DAY -2-2
10NUTR123LBNUTR123_00110D-2_22COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-03 T20:00DIARY DAY -2-2
11NUTR123LBNUTR123_00111D-1_11CONSIST
Consistency
Hard


Hard





STOOLCAREGIVER

2017-01-04 T09:00DIARY DAY -1-1
12NUTR123LBNUTR123_00112D-1_11COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-04 T09:00DIARY DAY -1-1
13NUTR123LBNUTR123_00113D-1_22CONSIST
Consistency
Loose


Loose





STOOLCAREGIVER

2017-01-04 T21:00DIARY DAY -1-1
14NUTR123LBNUTR123_00114D-1_22COLORColor
Brown


Brown





STOOLCAREGIVER

2017-01-04 T21:00DIARY DAY -1-1
The relrec.xpt example is represented below.
 relrec.xpt

relrec.xpt

Row

STUDYID

DOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1NUTR123CE
CEREFID
ONE1
2NUTR123LB
LBREFID
MANY1

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