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Example

This example shows how to represent baseline stool information for recall average number of bowel movements and recall typical stool consistency over a 3-day period prior to the baseline visit.

At the baseline visit, the subject was asked:

  • What was the average number of stool episodes per day over the 3 days prior to the visit?
  • What was the typical consistency of the stools over the 3 days prior to the visit?

FAOBJ Hidden/pre-populated
BOWEL MOVEMENT
FAEVINTX FAEVINTX and LBEVINTX Hidden/pre-populated
PREVIOUS 3 CALENDAR DAYS
Record the average number of stool episodes per day over the last 3 days that the subject recalls from memory.
EVENTFRQ_FAORRES FAORRES where FATESTCD = "EVENTFRQ"
_________________
EVENTFRQ_FASOURCE NSV.FASOURCE where FATESTCD = "EVENTFRQ" Hidden/pre-populated
RECALL
EVENTFRQ_FACOLSRT NSV.FACOLSRT where FATESTCD = "EVENTFRQ" Hidden/pre-populated
AVERAGE
EVENTFRQ_FATEST FATEST where FATESTCD = "EVENTFRQ" Hidden/pre-populated
Event Frequency
EVENTFRQ_FAORRESU FAORRESU where FATESTCD = "EVENTFRQ" Hidden/pre-populated
/day
Record the subject's assessment of the typical consistency of their stools over the last 3 days based on their recall from memory. Over the last 3 days what was the typical consistency of bowel movements?
CONSIST_LBORRES LBORRES where LBTESTCD = "CONSIST"
CONSIST_LBSOURCE NSV.LBSOURCE where LBTESTCD = "CONSIST" Hidden/pre-populated
RECALL
CONSIST_LBCOLSRT NSV.LBCOLSRT where LBTESTCD = "CONSIST" Hidden/pre-populated
TYPICAL
CONSIST_LBTEST LBTEST where LBTESTCD = "CONSIST" Hidden/pre-populated
Consistency
 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/A

FAOBJ
N/A
BOWEL MOVEMENT
hidden
Findings02FATAUG-NUT v1.0-Baseline Information on bowel movementsFAEVINTXEvaluation Interval TextN/AN/AtextN/A

FAEVINTX and LBEVINTX
N/A
PREVIOUS 3 CALENDAR DAYS
hidden
Findings03FATAUG-NUT v1.0-Baseline Information on bowel movements EVENTFRQ_FAORRES
Over the last 3 days what was the average number of bowel movements per day?Avg Number of Bowel MovementstextRecord the average number of stool episodes per day over the last 3 days that the subject recalls from memory.

FAORRES FAORRES where FATESTCD = "EVENTFRQ"N/A



Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsEVENTFRQ_FASOURCESource of DataN/AN/Atext


NSV.FASOURCENSV.FASOURCE where FATESTCD = "EVENTFRQ"N/A
RECALL
hidden
Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsEVENTFRQ_FACOLSRTCollected Summary Result TypeN/AN/Atext


NSV.FACOLSRT NSV.FACOLSRT where FATESTCD = "EVENTFRQ"N/A
AVERAGE
hidden
Findings05FATAUG-NUT v1.0-Baseline Information on bowel movementsEVENTFRQ_FATESTFindings About Test NameN/AN/Atext


FATEST FATEST where FATESTCD = "EVENTFRQ"N/A
Event Frequency
hidden
Findings06FATAUG-NUT v1.0-Baseline Information on bowel movementsEVENTFRQ_FAORRESUFindings About Result UnitN/AN/Atext


FAORRESU FAORRESU where FATESTCD = "EVENTFRQ"N/A
/day
hidden
Findings07LBTAUG-NUT v1.0-Baseline Information on bowel movements CONSIST_LBORRESResult or Finding in Original UnitOver the last 3 days what was the typical consistency of bowel movements?Typical Consistency of Bowel MovementstextRecord the subject's assessment of the typical consistency of their stools over the last 3 days based on their recall from memory. Sponsors should provide guidelines to subjects on how to evaluate "typical" consistency.
FAORRES LBORRES where LBTESTCD = "CONSIST"N/AWatery;Loose;Soft;Formed;Hard


Findings
LBTAUG-NUT v1.0-Baseline Information on bowel movementsCONSIST_LBSOURCESource of DataN/AN/Atext


NSV.LBSOURCENSV.LBSOURCE where LBTESTCD = "CONSIST"

RECALL
hidden
Findings08LBTAUG-NUT v1.0-Baseline Information on bowel movementsCONSIST_LBCOLSRTCollected Summary Result TypeN/AN/Atext


NSV.LBCOLSRT

NSV.LBCOLSRT

where LBTESTCD = "CONSIST"

N/A
TYPICAL
hidden
Findings09LBTAUG-NUT v1.0-Baseline Information on bowel movementsCONSIST_LBTESTName of Measurement, Test or ExaminationN/AN/Atext


LBTEST LBTEST where LBTESTCD = "CONSIST"N/A
Consistency
hidden
See Section 1.3, CDASH Metadata and Annotated CRFs, for explanation of annotations.

The NSV FASOURCE was used to represent that that the results of this data were obtained using subject recall at the visit, as opposed to information gathered from a data collection tool (e.g., patient daily diary). Recalled average number of bowel movements over a 3-day period prior to the visit is represented in the FACE domain. The NSV FACOLSRT was used to represent that the collected result type was an average.

 face.xpt

face.xpt

Row

STUDYID

DOMAIN

USUBJID

FASEQ

FATESTCD

FATEST

FAOBJ

FAORRES

FAORRESU

FASTRESC

FASTRESNFASTRESU

VISITNUM

VISIT

VISITDY

FADTC

FAEVINTX
FACOLSRTFASOURCE
1NUTR123FANUTR123_0011EVENTFRQEvent FrequencyBOWEL MOVEMENT3/day33/day1Baseline-12017-01-05PREVIOUS 3 CALENDAR DAYS
AVERAGERECALL

FACE NSV Metadata

Recalled typical consistency of the stool over a 3-day period prior to the visit  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. The NSVs LBCOLSRT and LBSOURCE were used to represent that the collected result was typical and that this was information recalled from the subject.
 lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBREFID

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESU

LBORNRLOLBORNRHI

LBSTRESC

LBSTRESNLBSTRESULBSTNRLOLBSTNRHILBSTREFCLBNRINDLBSPECLBEVAL

VISITNUM

VISIT

VISITDY

LBDTC

LBEVINTX
LBCOLSRTLBSOURCE
1NUTR123LBNUTR123_001
CONSISTConsistency
Loose


Loose





STOOLSUBJECT1Baseline-12017-01-05PREVIOUS 3 CALENDAR DAYS
TYPICALRECALL

LB NSV Metadata

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