in the data reported by cage; animal; e.g. each of those collection system, e.g. two animals per two animals consumes but then reported cage result in a food 50 g/animal/day. Study by animal in the consumption of 100 g report should describe report tables. The / day in total. POOLID reporting logic SEND reporting would have been system is then likely created for the two to report by cage, animals. unless manual intervention is done. Numeric ophthalmic May be present Low data (results of a microscopic (e.g. slit lamp) ophthalmic examination) and Dermal data are May not be present May be present Low present in study report, but not in the SEND Datasets. Values for body Values will be Values could be reported Low weight gain are reported interval to cumulatively or in another represented interval, but intervals customized way Body-weight differently between may vary gains over any SEND dataset and Report may include interval can be study report. additional cumulative calculated gains (e.g., from start to from BW data termination or for if needed by recovery phase). reviewers. Report may contain no body-weight gain data. CLSTRESC was less SENDIG has no single Report format may vary Low detailed than the (standard) by testing facility and/or Importance Study representation for CL data collection system. relative to Report in three data. efforts being studies evaluated. Table 2. High Impact Discrepancies- Reconcile if possible and if not, explain discrepancy in the nSDRG. Scenario # Brief Description SEND Dataset Study Report
in the data collection system, but then reported by animal in the report tables. The SEND reporting system is then likely to report by cage, unless manual intervention is done. reported by cage; e.g. two animals per cage result in a food consumption of 100 g / day in total. POOLID would have been created for the two animals. animal; e.g. each of those two animals consumes 50 g/animal/day. Study report should describe reporting logic Numeric ophthalmic data (results of a microscopic (e.g. slit lamp) ophthalmic examination) and May be present Low Dermal data are present in study report, but not in the SEND Datasets. May not be present May be present Low Values for body weight gain are represented differently between SEND dataset and study report. Values will be reported interval to interval, but intervals may vary Values could be reported cumulatively or in another customized way Report may include additional cumulative gains (e.g., from start to termination or for recovery phase). Report may contain no body-weight gain data. Low Body-weight gains over any interval can be calculated from BW data if needed by reviewers. CLSTRESC was less detailed than the Study Report in three studies SENDIG has no single (standard) representation for CL data. Report format may vary by testing facility and/or data collection system. Low Importance relative to efforts being evaluated. Table 2. High Impact Discrepancies- Reconcile if possible and if not, explain discrepancy in the nSDRG. Scenario # Brief Description SEND Dataset Study Report
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