Wound care clinical trial documentation: FAQ for investigators
clinicaltrials
Common questions from PIs and coordinators on source notes, measurement variance, eligibility evidence, and ALCOA+ compliance in wound trials.
Investigators and coordinators ask the same questions when a wound care trial starts up. Here are direct answers.
What counts as a source document in a wound trial visit?
The signed clinical note created at or immediately after the encounter — including the wound image, measurements, and assessment. CRF entries are transcriptions of source, not source themselves. An AI scribe for wound care generates the note during the visit; the investigator signs it before it becomes source.
How do we handle inter-rater variability in wound measurement?
Standardize the capture method. Manual tracings and rulers introduce 10–44% variance between raters. Markerless planimetry via AI-powered wound imaging applies the same algorithm to every image, so area and depth are comparable across visits, sites, and raters.
How do we prove a participant met inclusion criteria?
Each criterion needs a traceable evidence source: imaging for wound size, vascular study for perfusion, labs for HbA1c, and the visit note for duration and infection status. Keep them linked to the signed note.
What about the 20% run-in shrinkage rule?
Most DFU protocols exclude wounds that heal more than 20% during a 2-week run-in. Consistent measurement is the only way to defend that decision. A healing dashboard shows the percent change per visit.
Does the investigator still need to sign every visit?
Yes. AI drafts; investigators review and sign. Nothing is source until signed.
Where does ALCOA+ come in?
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available. Real-time capture with an audit trail hits all of them.
Bring your protocol and we'll walk through the specifics.