In our study (already locked), we found an issue where the same subject has been assigned two different USUBJIDs — one at screening and another at rescreening. This creates challenges because: Normally, each subject should have only one unique USUBJID across the study. Simply replacing the earlier USUBJID with the rescreened one could cause problems, since some datasets may have flags or derivations tied to SUBJID/USUBJID. Domains like DS, SE, and SV are especially affected. At the output level, the impact is minimal — it only affects disposition screen counts and screen failure counts. Our question: Is it acceptable to leave ADaM and SDTM datasets as-is (with the duplicate USUBJID issue) and instead address this only in the disposition output? We could then provide an explanation of this approach in the Reviewer’s Guide for transparency. Has anyone encountered a similar issue before? If so, how did you resolve it? Any advice or examples would be greatly appreciated. ... View more

Hi everyone, I'm working on SDTM AE data, and we have a case where a single adverse event (e.g., headache) increases in severity and later becomes serious. As per CDISC and FDA guidance, we're splitting this into multiple AE records using AELINKID . The issue we're debating is what to use for AEOUT in the intermediate records. Technically, the AE isn't "recovered" at that point — it's just getting worse. But if we set AEOUT = "Not recovered/Not resolved" and still provide an AEENDTC , it triggers FDA validation rule SD1332, which flags this combination as invalid. So the question is:  How should we populate AEOUT in intermediate split records when the AE hasn't truly resolved, but we need to avoid the SD1332 validation error? Are we supposed to use "Recovered/Resolved" just to avoid the rule, even if clinically it feels inaccurate? Appreciate any thoughts or examples of how others are handling this. ... View more