historical or legacy term.

Here’s the progression:

• ICH E6(R2): Used source documents and source data.
• ICH E6(R3): Replaced source documents with source records and broadened the concept to include documents, data, and relevant metadata, in any format.

The change is deliberate. “Document” implies a document-like artifact (paper, PDF, etc.), whereas “record” is technology-neutral and better covers:

• eSource systems
• EHRs
• Medical devices
• Wearables
• Imaging systems
• Audit trails and metadata
• Databases

As a result, source records is now the preferred concept.