s Sunil Kumar


Hi There, For our new study we are following 3.1.3 SDTM implementation. We are validating the domains with 1.4 validator against 3.1.3. I observe few issues as specified below along with variable length warning/error messages which we took care by creating a macro to assign the exact length based on highest length of the observations at the end. 1. I am getting a constant warning message of 'FDA Expected variable not found' for EPOCH in many domains. Is it mandatory to include EPOCH in all those domains? 2. Even though the label for ACTARM, CMTRT is correct, I am getting the warning of 'SDTM/dataset variable label mismatch'. 3. In DS, I am getting the warning of 'Missing DSDY variable, when DSDTC variable is present'. 4. In LB, I am getting the error of 'LBTEST and LBTESTCD values do not have the same Code in CDISC CT'. I used 'DRUGSCRN', and 'HEMIND' in LBTESTCD, and 'Drug Screen Panel' and 'Hemolysis' for LBTEST For some other tests I am getting the warning of 'Value for LBTEST/LBTESTCD not found in respective CT codelist' which is understandable but for these above specified, along with the warning messages I am getting the error message too. Is there anything that we are missing or are issues like these be taken care in 1.4.1? I appreciate all the replies/solutions. Thanks, Sunil

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