PRODUCT UPDATES · JUL 17, 2026 · 3 MIN READ
A clinician review workflow that signs exactly what was reviewed
Burna AI's clinician review workflow now signs a fixed snapshot of the reviewed grades, and every clinician-added adverse event lands on the right record.
Burna AI Team
A clinician review workflow is the sequence in which a clinician checks each AI-proposed adverse event grade, accepts, edits or dismisses it, and adds any event the AI did not propose, before an investigator signs the result. In Burna AI that workflow runs on the platform at app.burna.ai. The changes below were built on a development branch in July 2026 and went live on 10 August 2026: the signature now covers exactly the findings the clinician reviewed, and every clinician-added adverse event lands on the right record.
It serves the coordinators who review grades and the investigators who sign them.
How the clinician review workflow works in Burna AI
- Each proposed grade arrives with its CTCAE criterion and the line in the note that produced it.
- The clinician accepts, edits or dismisses each grade, and can add an adverse event the run did not propose.
- A qualified investigator signs the reviewed findings with a 21 CFR Part 11 electronic signature.
The AI proposes and shows its working; the clinician decides every grade. Who makes the final call on a grade sets out that boundary.
Sign-off covers an exact snapshot of the reviewed grades
Sign-off now signs an immutable snapshot of the reviewed findings: the accepted and edited grades exactly as they stood at the moment of signing. A grading run can be re-run or retried, so its raw output is never the signed record. The server derives the snapshot, so the signer's screen never decides what a signature covers.
21 CFR 11.70 requires a signature to be linked to its record so that it "cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means." The snapshot is what holds that link:
- An edit after signing makes the filing stale until it is signed again.
- A second sign-off adds a new version and leaves the first untouched.
- Before graded output is written back to the medical record, the platform checks that the signature still covers it.
How Burna AI approaches 21 CFR Part 11 covers signatures and the audit trail in full.
Clinician-added adverse events: new, continuing or recurring
When a clinician records an adverse event for a trial participant, the platform decides whether it is a new event, a continuation of one still open, or a recurrence of one that resolved. It decides from what the participant's record already holds:
| What the record shows for this term | Outcome |
|---|---|
| No earlier occurrence | New event |
| Exactly one earlier occurrence, still open | Continuation |
| The latest earlier occurrence resolved, and this one was observed after it | Recurrence |
| Anything else | Held for a clinician to confirm |
A continuation keeps the original onset date, so the event's duration stays intact. Its signature is cleared only when the grade changes: a move from grade 2 to grade 3 is a new clinical assertion and needs a new signature, while recording a stable event again at the next visit does not.
The rule uses no fixed day window, because a return within a set number of days means different things for different terms. Where the record cannot decide, the platform writes nothing and returns the candidate earlier occurrence as a question. The clinician's answer is checked against the participant's own record of the same term before anything is recorded.
Since then (7 September 2026): the platform captures the date each adverse event began and reads it back.
Retry a stalled step without losing reviewed grades
If drug attribution or interaction screening stalls after grading completes, the encounter now offers Retry for that step alone. Grading does not run again, so the grades a clinician has already reviewed stay exactly where they are.
Search the encounter queue by patient, MRN or day
The encounter list is the review queue. It gained server-side search across visit title, note excerpt, patient name and MRN, and a day picker for the date a visit was recorded, so a coordinator goes straight to the encounter waiting for review.
A team workspace that always has an owner
- A newly created workspace becomes its creator's active workspace.
- The sole owner of a shared workspace transfers ownership before their account can be deleted, so the team's workspace always has an owner.
- Banning a user ends their live sessions at once.
- A password reset sends its link by email and is recorded in the audit trail.
Where this runs today
The 10 August release also retired the earlier provider web app; the platform runs at app.burna.ai. What Burna AI does today lists every live capability.
AI suggests, clinicians decide. Human-in-the-loop, always.
If your coordinators review and sign adverse event grades, book a 15-minute conversation.