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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

  • Stool Color Consistency and Weight: Discussions have been ongoing about the modeling of data such as stool samples (e.g., stool color, stool consistency and stool weight) and if these data should be modelled in the Laboratory Test Results (LB) domain or the Biospecimen Findings (BS) domain. The following recommendations were provided by CDISC and reviewed by the CDISC Global Governance Group. The LB Domain should be used to represent data about specimens that are removed from the body and undergo an observation or test that inform about the state of the subject (e.g., color, volume, pH, measurement of an analyte). In contrast, the BS Domain should be used to represent information about the sample that is not meant to inform about the health of the subject (e.g., tracking, sample condition, amount of specimen available for testing (when that information is used to keep track for testing), test run dates). Therefore, in this User Guide these assessments have been represented using the Laboratory Test Results (LB) domain since the tests were performed in order to inform about the state of the subject. NUT-120 - Getting issue details... STATUS   NUT-112 - Getting issue details... STATUS
  • 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 (e.g., 21:30 on one day to 21:30 on the next day). NUT-121 - Getting issue details... STATUS
  • 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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