Signed source notes for wound trials: inside the AI scribe agent
clinicaltrials
How the AI scribe agent drafts wound visit notes that clear investigator review and stand up as ALCOA+ source documents in a trial audit.
In a wound trial, the visit note isn't just clinical documentation — it's the source document a monitor will trace every CRF entry back to. Here's how the AI scribe agent produces notes that hold up.
What the agent captures
The AI scribe for wound care listens to the visit conversation and drafts a structured wound note with:
- Wound location, etiology, and stage
- Measurements pulled from the imaging agent (not re-typed)
- Assessment of infection, exudate, tissue type, and periwound skin
- Treatment performed and products applied
- Plan, follow-up, and protocol-specific fields
Draft, review, sign — in that order
The agent never signs. It drafts. The investigator reads the note, edits as needed, and applies their signature. The signature timestamp is the moment the note becomes source.
ALCOA+ by construction
- Attributable — every edit is tied to a user account
- Legible — structured text, not handwriting
- Contemporaneous — drafted during the visit, signed before the participant leaves
- Original — the signed note, with its image attachments, is the origin
- Accurate — measurements come from the imaging agent, not memory
- Plus Complete, Consistent, Enduring, Available in the audit trail
Protocol-specific fields
Bring your CRF. The scribe can prompt for protocol-required elements (perfusion status, offloading adherence, adverse events) so the note is complete on the first pass.
One capture, one signature, one source
No dual documentation. No end-of-day catch-up. Start free and try it on a live trial visit workflow.