Data is collected for Data may be present Data may not be present. Low investigative if collected in data purposes or capture system. veterinary assessments (e.g., body temperature). Unscheduled Data will not be May be explained in the Low veterinary present. study report. assessments may be included in the study report, but not in the SEND datasets. Sentinel animals May or may not be Will not be present Low included as part of present carcinogenicity studies could be included in the trial design domains. In the study report One of the following Age at time of receipt or Low the age at time of variables will be age at time of dose will be receipt is frequently present: reported. listed; in the DM AGE = exact date domain the required AGETEXT = range data references age Both refer to age at at start of dose. start of dose. Instruments or It may or may not be Not all testrelated data Low equipment collect possible to filter out are reported. more test-related testrelated data not data than are being reported. required by protocol. Animals are There are a variety of Data may or may not be Low "swapped" or processes for present.However, an substituted out prior replacing animals explanation of the to or after first dose assigned to study and replacement will likely be (e.g., replacement epending on tool or present. If it is after the animals). processes used, data first dose, the explanation may or may not be should be clear enough to present. avoid questions. Food in/out Value will be Value will be represented Low iscollected daily but represented as daily as weekly consumption. reported weekly consumption. Food consumption Food consumption Food consumption data Low is collected per cage data may be may be reported by
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
10_24_2017_Data_Inconsistency_WP_Review_%283%29_ddo.docx