Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality

Oversight of clinical investigations- A risk based approach to monitoring

Taghrid Obied · Pharmaceutical Regulatory Affairs Open Access · 2014 · 87 citations

Pharmacy, Clinical Sciences, Clinical Research Regulation +8

The potential for central monitoring techniques to replace on-site monitoring: findings from an international multi-centre clinical trial

Julie Bakobaki, Mary Rauchenberger, Nicola Joffe et al. · Clinical Trials · 2011 · 86 citations

Public Health, Health Sciences, Preventive Medicine +17

The Value of Source Data Verification in a Cancer Clinical Trial

Catrin Tudur Smith, Deborah Stocken, Janet Dunn et al. · PLoS ONE · 2012 · 81 citations · Full text

Medicine, Oncology, Clinical Data Management +16

Reflection paper on risk based quality management in clinical trials

Canary Wharf, Edythe D. London · 2013 · 76 citations

Management, Quality Management, Risk Management +15

Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database

Jules T. Mitchel, Yong Joong Kim, Joonhyuk Choi et al. · Drug Information Journal · 2011 · 50 citations · Full text

Health Professions, Biomedical Informatics, Health Informatics +14