Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials - Andersen, Jeppe Ragnar; Byrjalsen, Inger; Bihlet, Asger; Kalakou, Faidra; Hoeck, Hans Christian; Hansen, Gitte; Hansen, Henrik Bo; Karsdal, Morten Asser; Riis, Bente Juel (British journal of clinical pharmacology, 2015)
Keywords: 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