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).
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.
- 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).
- The GI symptoms were assessed by the subject therefore FAEVAL was used to represent this. - NUT-136Getting issue details... STATUS
- 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-47Getting issue details... STATUS
|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).|
|No||N||SUBJECT||2017-01-05||END OF DIARY DAY 2||2|
|2||NUTR123||FA||NUTR123_001||2||2||OCCUR||Occurrence Indicator||FLATULENCE||GI SYMPTOMS||No||N||SUBJECT||2017-01-05||END OF DIARY DAY 2||2||-P1D|
|3||NUTR123||FA||NUTR123_001||3||3||OCCUR||Occurrence Indicator||BURPING||GI SYMPTOMS||Yes||Y||SUBJECT||2017-01-05||END OF DIARY DAY 2||2||-P1D|
|4||NUTR123||FA||NUTR123_001||4||3||SEV||Severity/Intensity||BURPING||GI SYMPTOMS||Mild||MILD||SUBJECT||2017-01-05||END OF DIARY DAY 2||2||-P1D||MAXIMUM|
|5||NUTR123||FA||NUTR123_001||5||1||OCCUR||Occurrence Indicator||DIARRHEA||GI SYMPTOMS||No||N||SUBJECT||2017-01-06||END OF DIARY DAY 3||3||-P1D|
|6||NUTR123||FA||NUTR123_001||6||2||OCCUR||Occurrence Indicator||FLATULENCE||GI SYMPTOMS||Yes||Y||SUBJECT||2017-01-06||END OF DIARY DAY 3||3||-P1D|
|7||NUTR123||FA||NUTR123_001||7||2||SEV||Severity/Intensity||FLATULENCE||GI SYMPTOMS||Moderate||MODERATE||SUBJECT||2017-01-06||END OF DIARY DAY 3||3||-P1D||MAXIMUM|
|8||NUTR123||FA||NUTR123_001||8||3||OCCUR||Occurrence Indicator||BURPING||GI SYMPTOMS||Yes||Y||SUBJECT||2017-01-06||END OF DIARY DAY 3||3||-P1D|
|9||NUTR123||FA||NUTR123_001||9||3||SEV||Severity/Intensity||BURPING||GI SYMPTOMS||Severe||SEVERE||SUBJECT||2017-01-06||END OF DIARY DAY 3||3||-P1D||MAXIMUM|
Dataset Debug Message
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FACE NSV Metadata