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NUT-60 - Getting issue details... STATUS Nutrition studies often provide the subject with a diary in order to provide daily information on GI symptoms (e.g., nausea, vomiting, burping, abdominal distension, flatulence, colic/cramps, regurgitation, diarrhea, constipation).

Example

In this example the subject was given a diary at Visit 1 to record their GI symptoms starting from the day after Visit 1 to the day before Visit 2. The diary was then collected at Visit 2 and a new diary given to the subject.

NUT-138 - Getting issue details... STATUS

FAEVLINT Hidden/pre-populated
-P1D
Select the diary day being entered. What is the diary day?
FATPT
Record the date the subject indicated the diary was completed.
FADAT FADTC
_________________
NAUSEA_FAOBJ FAOBJ Hidden/pre-populated
NAUSEA
Record whether the subject experienced nausea. Did the subject experience nausea?
NAUSEA_OCCUR_FAORRES FAORRES where FAOBJ = "NAUSEA" and FATESTCD = "OCCUR"
If the subject experienced nausea, complete the maximum severity over the day. If "Yes," what was the maximum severity?
NAUSEA_SEV_FAORRES FAORRES where FAOBJ = "NAUSEA" and FATESTCD = "SEV"
NAUSEA_SEV_FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "NAUSEA" Hidden/pre-populated
MAXIMUM
FLATULENCE_FAOBJ FAOBJ Hidden/pre-populated
FLATULENCE
Record whether the subject experienced flatulence. Did the subject experience flatulence?
FLATULENCE_OCCUR_FAORRES FAORRES where FAOBJ = "FLATULENCE" and FATESTCD = "OCCUR"
If the subject experienced flatulence, complete the maximum severity over the day. If "Yes," what was the maximum severity?
FLATULENCE_SEV_FAORRES FAORRES where FAOBJ = "FLATULENCE" and FATESTCD = "SEV"
FLATULENCE_SEV_FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "FLATULENCE" Hidden/pre-populated
MAXIMUM
BURPING_FAOBJ FAOBJ Hidden/pre-populated
BURPING
Record whether the subject experienced burping. Did the subject experience burping?
BURPING_OCCUR_FAORRES FAORRES where FAOBJ = "BURPING" and FATESTCD = "OCCUR"
If the subject experienced burping, complete the maximum severity over the day. If "Yes," what was the maximum severity?
BURPING_SEV_FAORRES FAORRES where FAOBJ = "BURPING" and FATESTCD = "SEV"
BURPING_SEV_FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "BURPING" Hidden/pre-populated
MAXIMUM
 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 movementsFAEVLINTEvaluation IntervalN/AN/AtextN/A

FAEVLINT
N/A
-P1D
hidden
Findings02FATAUG-NUT v1.0-Baseline Information on bowel movementsFATPTPlanned Time Point NameWhat is the diary day?Diary DaytextSelect the diary day being entered.

FATPT
N/ADIARY DAY 1; DIARY DAY 2; DIARY DAY 3


Findings03FATAUG-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.

FADTC





Findings04FATAUG-NUT v1.0-Baseline Information on bowel movementsNAUSEA_FAOBJFinding About ObjectN/AN/AtextN/A

FAOBJ
N/A
NAUSEA
hidden
Findings05FATAUG-NUT v1.0-Baseline Information on bowel movements NAUSEA_OCCUR_FAORRESFindings About ResultDid the subject experience nausea?NauseatextRecord whether the subject experienced nausea.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
FAORRES FAORRES where FAOBJ = "NAUSEA" and FATESTCD = "OCCUR"N/AYes;No


Findings06FATAUG-NUT v1.0-Baseline Information on bowel movements NAUSEA_SEV_FAORRESFindings About ResultIf "Yes," what was the maximum severity?SeveritytextIf the subject experienced nausea, complete the maximum severity over the day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES FAORRES where FAOBJ = "NAUSEA" and FATESTCD = "SEV"N/AMild;Moderate;Severe


Findings07FATAUG-NUT v1.0-Baseline Information on bowel movements

NAUSEA_SEV_FACOLSRT

Collected Summary Result TypeN/AN/Atext
An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

NSV.FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "NAUSEA"N/A
 MAXIMUM
 hidden
Findings08FATAUG-NUT v1.0-Baseline Information on bowel movementsFLATULENCE_FAOBJFinding About ObjectN/AN/AtextN/AAn example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
FAOBJ
N/A
FLATULENCE
hidden
Findings09FATAUG-NUT v1.0-Baseline Information on bowel movements FLATULENCE_OCCUR_FAORRESFindings About ResultDid the subject experience flatulence?NauseatextRecord whether the subject experienced flatulence.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES FAORRES where FAOBJ = "FLATULENCE" and FATESTCD = "OCCUR"N/AYes;No


Findings10FATAUG-NUT v1.0-Baseline Information on bowel movements FLATULENCE_SEV_FAORRESFindings About ResultIf "Yes," what was the maximum severity?SeveritytextIf the subject experienced flatulence, complete the maximum severity over the day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES FAORRES where FAOBJ = "FLATULENCE" and FATESTCD = "SEV"N/AMild;Moderate;Severe


Findings11FATAUG-NUT v1.0-Baseline Information on bowel movements

FLATULENCE_SEV_FACOLSRT

Collected Summary Result TypeN/AN/Atext
An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

NSV.FACOLSRT NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "FLATULENCE"N/A
 MAXIMUM
 hidden
Findings12FATAUG-NUT v1.0-Baseline Information on bowel movementsBURPING_FAOBJFinding About ObjectN/AN/AtextN/AAn example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.
FAOBJ
N/A
BURPING
hidden
Findings13FATAUG-NUT v1.0-Baseline Information on bowel movements BURPING_OCCUR_FAORRESFindings About ResultDid the subject experience burping?NauseatextRecord whether the subject experienced burping.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES where FAOBJ = "BURPING" and FATESTCD = "OCCUR"
N/AYes;No


Findings14FATAUG-NUT v1.0-Baseline Information on bowel movements BURPING_SEV_FAORRESFindings About ResultIf "Yes," what was the maximum severity?SeveritytextIf the subject experienced burping, complete the maximum severity over the day.An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

FAORRES where FAOBJ = "BURPING" and FATESTCD = "SEV"
N/AMild;Moderate;Severe


Findings15FATAUG-NUT v1.0-Baseline Information on bowel movements

BURPING_SEV_FACOLSRT

Collected Summary Result TypeN/AN/Atext
An example of a CDASH denormalized variable name. This name includes the components needed to map to SDTM.

NSV.FACOLSRT where FATESTCD = "SEV" and FAOBJ = "BURPING"
N/A
 MAXIMUM
 hidden
See Section 1.3, CDASH Metadata and Annotated CRFs, for explanation of annotations.

Summarizing data of the daily diaries is generally done during the analysis stage and therefore only daily records are represented below. For the purposes of this example, only the first 2 days of the diary are shown.
  • Because the diary data is not visit-related, the sponsor chose to leave VISIT and VISITNUM blank.
  • The subject was instructed to complete the diary at the end of the day (represented in FATPT); to note if they had any of the symptoms over that day (FAEVLINT used to represent that the subject was assessing the symptoms over that day); and, if yes, the severity of the symptom over that day (again, FAEVLINT used to represent that the subject was assessing the symptoms over that day).
  • Please note that sponsors should provide instructions to investigational sites/subjects on how to assess severity of symptoms (e.g., the maximum severity over the day, the most common severity over the day). In this example, the sponsor provided instructions to record the worse (maximum) severity over the day. This is represented using the NSV FACOLSRT.  NUT-47 - Getting issue details... STATUS

 face.xpt
Rows 1-4:Show the diary results for diarrhea, flatulence, and burping for the first day of the diary (Day 2 of the study).
Rows 5-9:Show the diary results for diarrhea, flatulence, and burping for the second day of the diary (Day 3 of the study).

face.xpt

Row

STUDYID

DOMAIN

USUBJID

FASEQ

FASPID

FATESTCD

FATEST

FAOBJ

FACAT

FAORRES

FASTRESC

VISITNUM

FADTC

FATPTFATPTNUMFAEVLINT
FACOLSRT
1NUTR123FANUTR123_00111OCCUROccurrence Indicator

DIARRHEA

GI SYMPTOMS

NN
2017-01-05END OF DIARY DAY 22

-P1D



2NUTR123FANUTR123_00122OCCUROccurrence IndicatorFLATULENCEGI SYMPTOMSNN
2017-01-05END OF DIARY DAY 22-P1D

3NUTR123FANUTR123_00133OCCUROccurrence IndicatorBURPINGGI SYMPTOMSYY
2017-01-05END OF DIARY DAY 22-P1D

4NUTR123FANUTR123_00143SEVSeverity/IntensityBURPINGGI SYMPTOMSMildMILD
2017-01-05END OF DIARY DAY 22-P1D
MAXIMUM
5NUTR123FANUTR123_00151OCCUROccurrence IndicatorDIARRHEAGI SYMPTOMSNN
2017-01-06END OF DIARY DAY 33-P1D

6NUTR123FANUTR123_00162OCCUROccurrence IndicatorFLATULENCEGI SYMPTOMSYY
2017-01-06END OF DIARY DAY 33-P1D

7NUTR123FANUTR123_00172SEVSeverity/IntensityFLATULENCEGI SYMPTOMSModerateMODERATE
2017-01-06END OF DIARY DAY 33-P1D
MAXIMUM
8NUTR123FANUTR123_00183OCCUROccurrence IndicatorBURPINGGI SYMPTOMSYY
2017-01-06END OF DIARY DAY 33-P1D

9NUTR123FANUTR123_00193SEVSeverity/IntensityBURPINGGI SYMPTOMSSevereSEVERE
2017-01-06END OF DIARY DAY 33-P1D
MAXIMUM

FACE NSV Metadata

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