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Pareto — Clinical Trial Data Queries

Monitor-raised data queries by case-report-form field for a phase III study against the sponsor's previous one, computing that 5 of 13 fields generate 81.1% of 3,044 queries and that ECG capture entered the vital few this study.

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Data queries by CRF field — study CV-311, interim lockCV-311 interim lock vs CV-208 final lock · 13 categories · total 3,044 queries · threshold 80%CV-311 interim lockCV-208 final lockCumulative %Cumulative % (CV-208 final lock)02004006008001,0000%20%40%60%80%100%80% threshold964641622708418372274455190118168141150841405811813931.7%52.1%65.8%74.8%81.1%86.6%91.5%96.1%100%vital few · 5Adverse event onset dateConcomitant med doseVital signs out of rangeLab unit mismatchECG interval missingVisit date windowDosing diary gapInformed consent versionOther5 of 13 categories (38%) account for 81.1% of 3,044 queries.Vital few at 80%: Adverse event onset date, Concomitant med dose, Vital signs out of range, Lab unit mismatch, ECG interval missing —2,468 of 3,044 queries.Those categories covered 84.5% of the CV-208 final lock total (2,716 queries), against 81.1% of CV-311 interim lock.Movement vs CV-208 final lock: entered — ECG interval missing.Other folds 5 categories under 2% of total (118 queries, 3.9%).18,430 subject-visits across 74 sites — one query every 6.1 visits

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title "Data queries by CRF field — study CV-311, interim lock"
unit queries
period "CV-311 interim lock"
compare "CV-208 final lock"
threshold 80%
other-below 2%
note "18,430 subject-visits across 74 sites — one query every 6.1 visits"

# quoting a field called "Vital signs…" keeps it a data row, not a directive
"Adverse event onset date"      964     641
"Concomitant med dose"          622     708
"Vital signs out of range"      418     372
"Lab unit mismatch"             274     455
"ECG interval missing"          190     118
"Visit date window"             168     141
"Dosing diary gap"              150      84
"Informed consent version"      140      58
"Randomisation mismatch"         43      36
"Protocol deviation code"        31      47
"Pregnancy test missing"         22      19
"Sample chain of custody"        14      25
"Site signature missing"          8      12