Challenges in coding adverse events in clinical trials: a systematic review
Research output: Contribution to journal › Journal article › Research › peer-review
Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation. Adverse events are categorised by a predefined dictionary, e.g. MedDRA, which is updated biannually with many new categories. The objective of this paper is to study interobserver variation and other challenges of coding.
Original language | English |
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Journal | P L o S One |
Volume | 7 |
Issue number | 7 |
Pages (from-to) | e41174 |
ISSN | 1932-6203 |
DOIs | |
Publication status | Published - 2012 |
ID: 48458781