An independent field guide

Understand the science.
Read the data.
Build with context.

Learn clinical research software engineering: from electronic data capture (EDC) to CDISC standards and the Study Data Tabulation Model (SDTM). Explore clinical data concepts through guided lessons and synthetic examples.

For software engineers entering clinical research.

Observation 001Synthetic

A value is only the beginning.

72recorded as text
WHO
SYN-001 Subject identity
WHAT
DEMO_A Teaching token
WHEN
2025-02-03 Recorded date

Identity, meaning and timing turn a value into an observation you can reason about.

Follow this example
Model 2.0IG 3.4Content 1.0.0Curated educational coverage

Find your footing

A bridge between software
and clinical research.

No clinical background required. Bring your curiosity about how systems and data fit together.

  1. 01

    Build a mental model

    From studies and collection forms to the shape of a dataset. Eight connected lessons.

  2. 02

    Look inside a domain

    Explore six SDTM topics and 44 selected variable lessons, with context at every step.

  3. 03

    Trace an observation

    Inspect original synthetic inputs, output rows and the decisions between them.

Know the boundary

A learning companion.
With a clear trail to the source.

Every lesson distinguishes an authored explanation from an official rule. This curated edition links to the standards; it does not reproduce their metadata or validate clinical datasets.

How to read this field guide →