still an issue with 3.1. This has been clarified in 3.1 by way of further description in comments. LB (Laboratory Test Results) Domain LBORNRLO and LBORNRHI should be type Char, not Num. This has been corrected in 3.1. The CDISC notes in the domain description table for LBSTRESU currently includes a notation "Preferably SI units". Assumption 2a also includes a statement that values should be reported in SI units when possible. These are incorrect; there is no preference for SI units in SEND. This has been corrected in 3.1. OM (Organ Measurements) Domain The bolded portion of this statement in the implementation guide is incorrect: "Organ measurement ratios within a single study should either be pure ratios with no units specified or percentages with unit shown as “%”. There is a term "RATIO" in the controlled terminology UNIT codelist. Therefore organ-to-brain and organ-to-organ ratios should use RATIO (not blank) or % as the unit. This has been corrected in 3.1. PM (Palpable Masses) Domain The variable label for PMDTC should be "Date/Time of Observation" not "Start Date/Time of Observation". This has been corrected in 3.1. PC (Pharmacokinetics Concentrations) Domain The variable label for VISITDY should be "Planned Study Day of Collection", not "Visit Day", consistent with other domains. This has been corrected in 3.1. TF (Tumor Findings) Domain The variable shown as TSTFNAM should be TFNAM. This has been corrected in 3.1. The variable label for TFSPID should be "Mass Identifier", not "Mass Number". This has been corrected in 3.1. VS (Vital Signs) Domain The "Controlled Terms, Codelist, or Format" in the domain description table for DOMAIN should be "VS" and for VSDRVFL it should be "(NY)". This has been corrected in 3.1. |