In nonclinical studies it is common that a single finding may be captured for multiple subjects. Variable POOLID will be used with the Clinical Observation (CL), Food and Water Consumption (FW), Laboratory Test Results (LB), Pharmacokinetics Concentrations (PC), and Pharmacokinetics Parameters (PP) domains to support subject pooling in conjunction with the POOLDEF special-purpose domain. TOBA-804 - Getting issue details... STATUS

The following table lists some common examples where pooling may occur.

NumDomainExample
1Clinical Observations (CL)Clinical signs for group-housed subjects may contain cage-level findings for which a particular subject cannot or has not been identified. For example, the technician may notice liquid stool in the cage but did not see which subject produced the stool.
2Food and Water Consumption (FW)Food consumption for group-housed subjects may be recorded at the cage level. This method for pooling allows grams/cage/day or grams/cage/week to be reported.
3Laboratory Test Results (LB)In small-animal studies there may be scheduled clinical chemistry tests where a single subject may not be able to provide the volume of blood needed for testing. Therefore, blood from multiple subjects may be drawn to get the appropriate volume.
4Pharmacokinetics Concentrations (PC)In animal studies there may be scheduled blood draws at various time points, to be analyzed for the compound of interest. These concentrations are then used in pharmacokinetic or toxicokinetic calculations. A single subject may not be able to provide the volume of blood needed for testing and therefore blood from multiple subjects may be drawn to get the appropriate volume.
5Pharmacokinetics Parameters (PP)In most small animal studies it is not feasible to create a complete pharmacokinetic profile over time on an individual subject. Multiple subjects are sampled at any given time point and all contribute to a single pharmacokinetic profile. The POOLID reflects the pool of subjects that contributed to a pharmacokinetic profile. Note, however, that this does not indicate whether a subject contributed once or several times. In some instances, blood samples may have been pooled prior to analysis to achieve a certain volume, and POOLID will be reflected in the PC domain. When multiple pools in the PC domain contribute to a single pharmacokinetic profile, a new POOLID composed of all the subjects is used in PP.
POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will be null; if a USUBJID is recorded, the POOLID will be null. POOLID values are unique for a given set of subjects and a pool will consist of at least one subject. Although the same value of POOLID may not be re-used to refer to different sets of subjects, different POOLIDs may be used to refer to the same set of subjects. Because POOLID is unique for a set of subjects, a new POOLID must be generated if the subjects within the pool change. An example of this is when a member of a pool dies, and the number of subjects in the pool is either reduced or a new subject is assigned to that pool. The values of POOLID are applicant defined. Some examples of POOLIDs include:

  • A concatenation of subject IDs: "ABC-1001, ABC-1002, ABC-1003, Cage1-1001, Cage2-1002"
  • Cage identifier and study day: "Cage1-Day 1-Day-27, Cage1-Day-28-54"
  • Sequential: "POOL1," "POOL2"

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