For everyone who works where clinical research meets data: biostatisticians, statistical programmers, data managers, regulatory professionals and students entering the field. The course follows trial data on its journey from the case report form to the regulatory submission. It covers the CDISC standards (CDASH, SDTM, ADaM, Define-XML, Controlled Terminology and SEND) through worked dataset examples, and shows how every reported number traces back to its source. It closes with FDA-compliant tables, listings and figures, the pitfalls reviewers flag most often, and the ICH guidelines that shape modern submissions. This pack includes: a 5-minute introduction, a 43-minute main session, and downloadable explanatory notes to keep for reference.