COA Instruments
PerfO Administration: Record the Conditions Behind the Score
A practical PerfO administration record for trial teams, with six-minute walk evidence showing why task conditions matter and how to document deviations.
· · 13 min read
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How clinical trial teams apply RECIST 1.1 five-total, two-per-organ, paired-organ, and lymph-node rules to lock a baseline lesion record before follow-up.
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How clinical trial teams structure imaging charters to handle reader disagreement, unreadable series, and missing scans before database lock.
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How clinical trial teams choose wearable non-wear rules, define valid days, and distinguish missing observations from intercurrent events.
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Which endpoint data must be reconciled and evidenced before a clinical database lock, who signs each row, and how unlock and unblinding stay controlled.
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Decide which PRO questionnaires a clinical trial needs by mapping objectives, checking combined burden, and justifying timing in a hypothetical worked example.
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How to write ClinicalTrials.gov outcome measures from the protocol endpoint, which 42 CFR 11.64 update clock applies after an amendment, and what results QC checks.
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