Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials

• Published in: British journal of clinical pharmacology Vol. 79; no. 4; pp. 660 - 668
• Main Authors: Andersen, Jeppe Ragnar, Byrjalsen, Inger, Bihlet, Asger, Kalakou, Faidra, Hoeck, Hans Christian, Hansen, Gitte, Hansen, Henrik Bo, Karsdal, Morten Asser, Riis, Bente Juel
• Format: Journal Article
• Language: English
• Published: England Blackwell Science Inc 01.04.2015
• Subjects: Calcitonin - administration & dosage; Calcitonin - therapeutic use; Clinical Trials, Phase III as Topic - standards; Clinical Trials, Phase III as Topic - statistics & numerical data; cost‐benefit; Data Accuracy; data error analysis; Databases, Factual; Electronic Health Records - standards; Electronic Health Records - statistics & numerical data; Female; Forms and Records Control - methods; Forms and Records Control - standards; Forms and Records Control - statistics & numerical data; Humans; Methods in Clinical Pharmacology; monitoring; Osteoarthritis, Knee - drug therapy; Osteoporosis, Postmenopausal - drug therapy; Randomized Controlled Trials as Topic - standards; Randomized Controlled Trials as Topic - statistics & numerical data; risk‐based monitoring; source data verification; risk-based monitoring; data error analysis; source data verification; cost-benefit; monitoring

Aim The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach. Methods We used data from three randomized phase III tria...