Data is collected for investigative purposes or veterinary assessments (e.g., body temperature). Data may be present if collected in data capture system. Data may not be present. Low Unscheduled veterinary assessments may be included in the study report, but not in the SEND datasets. Data will not be present. May be explained in the study report. Low Sentinel animals included as part of carcinogenicity studies could be included in the trial design domains. May or may not be present Will not be present Low In the study report the age at time of receipt is frequently listed; in the DM domain the required data references age at start of dose. One of the following variables will be present: AGE = exact date AGETEXT = range Both refer to age at start of dose. Age at time of receipt or age at time of dose will be reported. Low Instruments or equipment collect more test-related data than are required by protocol. It may or may not be possible to filter out testrelated data not being reported. Not all testrelated data are reported. Low Animals are "swapped" or substituted out prior to or after first dose (e.g., replacement animals). There are a variety of processes for replacing animals assigned to study and epending on tool or processes used, data may or may not be present. Data may or may not be present.However, an explanation of the replacement will likely be present. If it is after the first dose, the explanation should be clear enough to avoid questions. Low Food in/out iscollected daily but reported weekly Value will be represented as daily consumption. Value will be represented as weekly consumption. Low Food consumption is collected per cage Food consumption data may be Food consumption data may be reported by Low
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
Numeric LB (and PC) values with leading characters (˃, <, etc.) or BLQ, or BLOQ are represented differently in SEND datasets and study report. LBORRES = BLOQ or LBORRES = <1 will result in null value for LBSTRESN; SUPPLB = numeric. “<”, “>” and numeric value will be present for purpose of calculation. High Correlations made in the study report are not reflected in RELREC (e.g. data is collected in 2 different systems) Relationships between data points may not be present only in RELREC Relationships between data points will be present 1. Datapoints labeled with “Day 0” may be present when in SEND dataset “Day 1” is expected Day 1 will be expected Day 0 will be reported Textual differences (controlled terminology) between reports and SEND data sets. Uses standard for Controlled Terminology May or may not use standard for Controlled Terminology. If the differences are impactful to data interpretation, it is recommended that they be listed out in the nSDRG Low/High Modifiers for pathology data may or may not be listed in the Study Report but should be in the SEND dataset (MA/MI domains) Modifiers will be listed in --SUPP and/or in addition to depending on how data are collected and base processes are defined. Modifiers may or may not be listed as part of base finding. May lead to differences in incidence counts. Nomenclature of severities may differ between SEND dataset and study report Will be present as Controlled Term because it is mapped to Controlled Terminology (CT). Severity will be listed as defined by sponsor. High