Summary of SEND Dataset Creation Process SEND Dataset Verification Study Design Study Design Summary (text here, if needed) Number of Animals Dose Dose Dose Main TK Level Concentration Volume Group Treatment Terminal Recovery Main mg/kg/day mg/mL mL/kg Male Female Male Female Male Female Trial Design Domain Overview The following diagram illustrates the trial design. (note: format is dependent on trial design; add or delete rows as needed.) Study Trial Arms Element in each Epoch Trial Set Group <EPOCH <EPOCH SPGRPCD ARMCD ARM name 1> <EPOCH name 2> name 3> SETCD SET <Set name 1> <Sponsors <Set name 2> group no.> <Set name 3> Standards, Formats, and Terminologies and their Versions Standards Used Standard or Dictionary Standard or Dictionary Versions Used Tabulation Datasets CDISC SEND Implementation Guide
Summary of SEND Dataset Creation Process SEND Dataset Verification Study Design Study Design Summary (text here, if needed) Number of Animals Group Treatment Dose Level Dose Concentration Dose Volume Main TK Terminal Recovery Main mg/kg/day mg/mL mL/kg Male Female Male Female Male Female Trial Design Domain Overview The following diagram illustrates the trial design. (note: format is dependent on trial design; add or delete rows as needed.) Study Group Trial Arms Element in each Epoch Trial Set SPGRPCD ARMCD ARM <EPOCH name 1> <EPOCH name 2> <EPOCH name 3> SETCD SET <Sponsors group no.> <Set name 1> <Set name 2> <Set name 3> Standards, Formats, and Terminologies and their Versions Standards Used Standard or Dictionary Standard or Dictionary Versions Used Tabulation Datasets CDISC SEND Implementation Guide