Topics

How these pages fit together

They follow the real journey of a datum, from record to analysable dataset, and read as well on their own as in order.

1. The clinical registry — the source, defined by a population rather than by a question.
2. Clinical data capture — the four routes by which an observation becomes a value.
3. The electronic case report form — the instrument of capture, and what separates it from a form.
4. AI-assisted extraction — the special case of free text, and its three constraints.
5. Clinical data quality — the measurable dimensions, and the ones that cannot be recovered.
6. The audit trail — what makes a change visible rather than impossible.
7. Clinical data management — the discipline linking every stage.
8. The clinical dataset — the deliverable, and the six pieces that compose it.

Topics

• AI-assisted clinical data extractionHow a model can extract variables from clinical reports without becoming an unverifiable source: mandatory citation, human validation, prior pseudonymisation.
• Clinical data captureThe four routes by which clinical data enters a database, what separates retrospective from prospective capture, and the design mistakes that cannot be undone.
• Clinical data managementWhat clinical data management is, why it determines how much an study can claim, how it is carried out stage by stage, and which standards apply.
• Clinical data qualityThe measurable dimensions of clinical data quality, the controls that produce it before rather than after capture, and what no amount of cleaning recovers.
• The audit trailWhat an audit trail is, what it must record, why a modifiable log proves nothing, and how hash-chaining makes tampering visible rather than preventing it.
• The clinical datasetWhat makes a clinical dataset usable: rectangular shape, dictionary, metadata, missing-value table, and preparation for SPSS, R and pandas.
• The clinical registryWhat a clinical registry is, how it differs from a study database, the design decisions that make it last, and the governance it requires.
• The electronic case report formWhat an eCRF is, the six properties that separate it from an ordinary web form, and how eCRF, collection form and variable dictionary relate.