Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal

vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues

(2013) Tomas Bergvall et al.   DRUG SAFETY

Differences between self-reported and verified adverse cardiovascular events in a randomised clinical trial

(2013) Mark J Bolland et al.   BMJ Open

Evaluation of Completeness of Suspected Adverse Drug Reaction Reports Submitted to the Mexican National Pharmacovigilance Centre

(2012) Betsabé Sánchez-Sánchez et al.   DRUG SAFETY

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration

(2012) Sonja Brajovic et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Quality of Methods for Assessing and Reporting Serious Adverse Events in Clinical Trials of Cancer Drugs

(2010) S M Belknap et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Quality check of spontaneous adverse drug reaction reporting forms of different countries

(2010) M. S. Bandekar et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

A prospective monitoring of fatal serious adverse events (SAEs) in a Dutch Colorectal Cancer Group (DCCG) phase III trial (CAIRO) in patients with advanced colorectal cancer

(2009) L. Mol et al.   ANNALS OF ONCOLOGY

Quality of Reporting of Serious Adverse Drug Events to an Institutional Review Board: A Case Study with the Novel Cancer Agent, Imatinib Mesylate

(2009) D. A. Dorr et al.   CLINICAL CANCER RESEARCH