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  • Non-Standard Variables: To make examples easier to understand, non-standard variables are shown as though they were appended to a dataset rather than being represented as supplemental qualifiers. This is also consistent with a proposed future structure for representing NSVs, a modification of the NSV proposal that went for public review and which is still under development (available in draft form at: NUT-52 - Getting issue details... STATUS A list of all NSVs used in this document, and the variable-level metadata that might become normative for the NSVs should they be promoted to standard variables, is provided in Appendix C, Non-Standard Variables

  • Baseline Stool Information: In this version of the TAUG-Nutrition, baseline bowel movement frequency and stool consistency NUT-55 - Getting issue details... STATUS has been represented as findings about bowel movement events in the FA domain NUT-53 - Getting issue details... STATUS . There have been discussions within the Global Governance Group (GGG) about modeling this type of data in the new Gastrointestinal (GI) domain. The advice from the GGG was to solicit feedback during the public review period NUT-54 - Getting issue details... STATUS and then re-address the modeling of this data during the public review comment resolution period.
  • Timing Variables: The time when a subject completes diary information may not be defined precisely by the sponsor. Instructions to subjects filling out a diary card might refer to calendar days (e.g., "Complete this diary with any relevant information from 00:00 on Day 1 to 11:59 on Day 1"), or might ask the subject to complete the diary card at the end of the day before retiring for the night (in which case any diary information after they retired for the night would be captured on the next day's diary). In the examples in this document, the --TPT value "END OF DIARY DAY X" is used to represent imprecise timing of diary data collection. NUT-56 - Getting issue details... STATUS The variables --EVLINT and --EVINTX are used to capture the evaluation interval. However, values such as -P1D are not intended to imply that data are collected in strict 24-hour intervals based on the time of  (e.g., 21:30 on one day to 21:30 on the next day).
  • Stool Measurements in the Lab Domain: At the time of internal review, the tests "Specimen Weight," "Color," and "Consistency" were under discussion by the LB Controlled Terminology Team. Therefore, modeling of these tests may change.
  • Modeling of Meal and Nutrient Data: The Combination Therapy sub-team are currently looking at the modeling of "product" and "ingredient" data in order to provide a consistent modeling approach across various projects. The modeling of meal, ingredients, and nutrient content as well as feeding recipes used in infant nutrition falls under the scope of the CT team. Modeling of these types of data is therefore not shown in this version of the TAUG-Nutrition.
  • Proposed Amendment to the Drug Accountability Domain: A proposal has been submitted to change the domain description from "drug accountability" to "product accountability" in order to extend the use of this domain. It is expected that this will be implemented in a future version of the SDTMIG. At the time of public review of this document, a draft domain has been created to document these changes. Please refer to Product Accountability (DA) for more information.
  • Representing Total Number of Breastfeeding Feeds per Day: This example uses the NSV EXNADEVI to represent the number of breastfeeding feeds per day. The modeling of this example is still under discussion and users are warned that this modeling may be subject to change.
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