Everything a statistical programmer needs for FDA regulatory submissions — eCTD structure, data standards, validation requirements, BIMO preparation, and downloadable checklists.
Electronic Common Technical Document — the standard format for FDA drug submissions
This is where statistical programmers live. Contains SDTM datasets, ADaM datasets, Define-XML, annotated CRFs, reviewer guides, and all study data packages.
Key Contents
Stat programmers: This is your Module. datasets/ folder contains tabulations/sdtm/ and analysis/adam/.
Downloadable Excel checklists — 3 sheets covering submission, CRF, and Define-XML validation
35+ items covering SDTM/ADaM datasets, Define-XML, annotated CRFs, reviewer guides, P21 validation, eCTD structure, and quality checks.
25+ checks for annotated CRFs — domain mapping, variable naming, CT alignment, Define.xml consistency, and PDF formatting.
47 checks covering schema validation, dataset/variable metadata, codelists, value-level metadata, ARM (v2.1), P21 rules, and cross-checks.
Bioresearch Monitoring — site inspection data packages with sample SAS programs
The FDA's Bioresearch Monitoring (BIMO) program conducts inspections of clinical investigator sites. When requested, sponsors must provide standardized data listings that enable FDA inspectors to compare submitted data against source documents at the site level. These outputs focus on per-site breakdowns to identify outliers, data inconsistencies, or protocol deviations at individual investigator sites.
Key point for programmers: BIMO outputs are generated from existing SDTM/ADaM datasets but reformatted as per-site listings and summaries. Build programs that accept site ID as a parameter so outputs can be generated for any site on demand.
Production-ready SAS macros parameterized by SITEID. Each program reads from standard SDTM/ADaM libraries and generates formatted PROC REPORT outputs. Download the package and adapt to your study.
bimo_disposition.sas
Subject disposition listing — parameterized by SITEID
bimo_ae_by_site.sas
AE frequency summary + detailed listing per site
bimo_enrollment_by_site.sas
Enrollment counts: screened, randomized, completed per site
bimo_protocol_deviations.sas
Protocol deviation summary + detailed listing per site
bimo_lab_shifts.sas
Lab shift tables (baseline → worst post-baseline) per site
Click any node for details — then "Ask AI" to query that standard's documentation
Ask questions about any standard in the ecosystem above — powered by a RAG model with document context from the SDTCG, Data Standards Catalog, SDTM-IG, ADaM-IG, Define-XML specs, ICH E3/E8/E9 guidelines, and more. Click any node in the diagram and press "Ask AI About This" to get focused answers from that standard.