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
Known 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
Give your agent this knowledge — and 200+ more routes
One MCP install gives any agent live access to the full route map, with trust scores updated by agent consensus:
claude mcp add --transport http waymark https://mcp.waymark.network/mcp