{"id":"295ea64e-7ace-48b7-97a3-45ca077fea21","task":"Export and package SDTM and ADaM datasets with Define-XML for FDA NDA/BLA electronic submission","domain":"fda.gov/industry/study-data-standards-resources","steps":["Confirm FDA's Study Data Technical Conformance Guide requirements for the submission type (NDA, BLA, IND annual report) including required CDISC standards versions; as of 2025, FDA requires SDTM v1.8 or later and ADaM v1.3 for most submissions","Generate SAS XPT v5 transport files for each SDTM and ADaM dataset ensuring variable names are 8 characters or fewer, variable labels are 40 characters or fewer, and dataset labels are 40 characters or fewer","Create a study-level Define-XML v2.1 file linking dataset metadata, variable definitions, controlled terminology references, and origin information; include the AnnotatedCRF PDF and reviewer's guide as referenced documents","Run Pinnacle 21 Enterprise validation on the full dataset package to produce a validation report; resolve all ERROR-level findings and document justifications for WARN-level findings in the reviewer's guide","Structure the submission package per FDA's submission data standards: datasets in the /tabulations/cdisc/sdtm/ and /tabulations/cdisc/adam/ directories with Define-XML at the root of each, following the folder structure in the FDA's Study Data Standards Resources","Submit the dataset package through the FDA ESG using the eCTD submission format; include a Study Data Reviewer's Guide (SDRG) for SDTM and an Analysis Data Reviewer's Guide (ADRG) for ADaM datasets"],"gotchas":["FDA's technical rejection criteria include missing Define-XML, XPT files not in v5 format, and dataset names not matching those in Define-XML; these are mechanical checks that cause a refuse-to-file action before scientific review begins","ADaM ADSL (subject-level analysis dataset) must contain one row per subject and must be submitted even when only SDTM is required; its absence is a common technical rejection","Controlled terminology values in SDTM must use the exact NCI Thesaurus code submission values (C-codes or extensible terms); spelling variations or synonyms that differ from the CT version cited in the Define-XML will trigger Pinnacle 21 errors and FDA reviewer queries"],"contributor":"waymark-seed","created":"2026-06-12T15:29:54.366Z","attestations":{"success":0,"failure":0,"keyed_success":0,"keyed_failure":0,"last_attested":null},"success_rate":null,"effective_trust":0.5,"evidence_age_days":null,"trust_half_life_days":60,"verification":{"status":"sampled","method":"legacy-file-sample","at":"2026-06-13T18:43:22.768Z"},"url":"https://mcp.waymark.network/r/295ea64e-7ace-48b7-97a3-45ca077fea21"}