Source document
In Documents & records
Also known as: source records
A source document is the original place where a piece of trial information was first recorded. Common examples are hospital notes, laboratory reports, signed consent forms, and device printouts. Data reported on the case report form must be traceable back to a source document.
Example
A blood pressure written straight into the eCRF and nowhere else makes the eCRF the source. This must be agreed and documented in advance in a source-data agreement, otherwise it looks like data with no origin.
Related terms
Career paths that use this
Go deeper
Turn the vocabulary into a career
The free CRLN Career Finder maps your background to a clinical-research role and builds a step-by-step roadmap. No cost, no card.
Get your free roadmap →Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.