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

British Journal of Clinical Pharmacology

Volumn 79, Issue 4, 2015, Pages 660-668

  Andersen, Jeppe Ragnar ^a   Byrjalsen, Inger ^a   Bihlet, Asger ^a   Kalakou, Faidra ^b   Hoeck, Hans Christian ^c   Hansen, Gitte ^a   Hansen, Henrik Bo ^a   Karsdal, Morten Asser ^a   Riis, Bente Juel ^a  

^a NORDIC BIOSCIENCE A S   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c CCBR   (Denmark)

Author keywords

cost benefit; data error analysis; monitoring; risk based monitoring; source data verification

Indexed keywords

SALCATONIN; CALCITONIN;

ARTICLE; COST BENEFIT ANALYSIS; DATA ANALYSIS; DATA BASE; DRUG EFFICACY; DRUG SAFETY; EVALUATION STUDY; HUMAN; INFORMATION PROCESSING; KNEE OSTEOARTHRITIS; MEASUREMENT ERROR; MONITORING; OSTEOPOROSIS; PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; POSTMENOPAUSE; PRIORITY JOURNAL; QUALITY CONTROL PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); SITE SOURCE DATA VERIFICATION; STATISTICAL ANALYSIS; VALIDITY; ELECTRONIC HEALTH RECORD; FACTUAL DATABASE; FEMALE; MEASUREMENT ACCURACY; MEDICAL RECORD; OSTEOARTHRITIS, KNEE; OSTEOPOROSIS, POSTMENOPAUSAL; PROCEDURES; STANDARDS; STATISTICS AND NUMERICAL DATA;

CALCITONIN; CLINICAL TRIALS, PHASE III AS TOPIC; DATA ACCURACY; DATABASES, FACTUAL; ELECTRONIC HEALTH RECORDS; FEMALE; FORMS AND RECORDS CONTROL; HUMANS; OSTEOARTHRITIS, KNEE; OSTEOPOROSIS, POSTMENOPAUSAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84925381466     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12531     Document Type: Article

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