Regulatory & CDISC Foundations

Start clinical programming in R with the foundations that make the rest make sense: how trial data flows from CRF to submission, who the regulators are, what an estimand is, and how the CDISC standards fit together. Concept-first, no pharmaverse setup required — the base for the hands-on series.

Learn › Pharma & Clinical › Regulatory & CDISC Foundations

Before you write a line of admiral or rtables, you need the map: where clinical trial data comes from, where it has to go, and the standards that govern every step. This series builds that base — concept-first, no pharmaverse setup required — so the hands-on SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), and TLF (tables, listings, and figures) lessons make sense from the start. It is free, the regulatory and CDISC (Clinical Data Interchange Standards Consortium) entry point to the whole pillar.

Read them in order:

1. Clinical trial data flow — follow one data point from the case report form through SDTM and ADaM to the TLF that go to the FDA, and see which CDISC standard and pharmaverse package owns each stage.
2. Regulatory context — who the regulators are (FDA, EMA, PMDA — the U.S., European, and Japanese drug agencies), what ICH (the International Council for Harmonisation) harmonizes, and why your study data must be standardized CDISC inside an eCTD (electronic Common Technical Document) submission.
3. Estimands — why the same trial data can answer different questions, and how the five estimand attributes and intercurrent-event strategies (ICH E9(R1)) pin down the one you mean.
4. The CDISC standards family — how CDASH (Clinical Data Acquisition Standards Harmonization), SDTM, ADaM, and Define-XML connect from data collection to a traceable submission.
5. From SAS to R — what the FDA actually accepts, what the R Consortium pilots and the pharmaverse proved, and what stays identical (the CDISC standards).

All lessons

🟢 With an AI agent

Ask Prova “what’s the difference between SDTM and ADaM, and why do I need both?” — it answers grounded in the CDISC standards and the actual data flow, so the model fits your study, not a generic example. The runtime is the judge. Ask Prova →

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