Find the ambiguous eligibility criteria, impossible visit windows, and schedule-of-assessments mismatches that turn into protocol deviations and amendments once the trial is live.
TrialScope · live audit
📄 Protocol + schedule of assessments🎯 Reviewing as: Clinical Operations
VERDICT
Revise to reduce deviation risk
FINDINGS
0 · 2 · 2
crit · major · minor
MAJORPopulation
'Moderate-to-severe' defined two different ways
Eligibility uses body-surface-area in one place and a PASI threshold in another without stating which governs — a predictable source of screening deviations.
MAJORSchedule
Week-12 PK draw missing from the schedule of assessments
The PK section requires a Week-12 sample; the schedule of assessments omits it, so sites will miss it unless the SoA is corrected.
MINORFeasibility
±1 day visit window on a 12-week visit is operationally tight
A ±1 day window on a quarterly visit will generate avoidable window deviations; consider ±3 days unless scientifically required.
MINORDeviation risk
Prohibited-medication washout not stated in days
The washout for a prohibited concomitant medication is described qualitatively; sites need a defined interval to screen consistently.
The review work that eats your week
Ambiguous or contradictory eligibility criteria that generate screening deviations
Schedule-of-assessments that disagrees with the body of the protocol
Visit windows and procedures that aren't operationally feasible at sites
Criteria that predictably drive amendments after first-patient-in
What TrialScope checks for you
Feasibility scan
Flags eligibility criteria, procedures, and visit windows that are ambiguous or hard to execute at sites.
Schedule consistency
Reconciles the schedule of assessments against the narrative — procedures, timepoints, and windows that don't match.
Deviation-risk flags
Highlights criteria and procedures that are common sources of protocol deviations.
Amendment-risk flags
Surfaces under-specified sections likely to require a post-FPI amendment.
SEE IT ON YOUR OWN DOCUMENT
Upload a protocol, CSR, manuscript, or briefing document and get an audit calibrated to clinical operations — findings, severities, and a verdict in under 90 seconds. Free to use.
Frequently asked questions
How does TrialScope help clinical operations?
It reviews a protocol for operational feasibility — ambiguous eligibility criteria, schedule-of-assessments mismatches, tight visit windows, and other deviation- and amendment-prone elements — so you can fix them before sites encounter them.
Does it check the schedule of assessments?
Yes. It reconciles the schedule of assessments against the body of the protocol and flags procedures, timepoints, or windows that disagree or are operationally impractical.
How is it calibrated for clinical operations?
Audits run through a clinical-operations persona, and corrections from verified operations professionals refine how it weights feasibility and deviation-risk findings over time.