Here are three common mistakes that occur in the reporting of adverse events in clinical trials:
- Failure to specify whether a local adverse event occurred at the drug administration site versus elsewhere. Seems obvious, eh? Yet it's amazing how often this detail is overlooked. Devise a way to distinguish between events at the drug administration site from events at other locations. Instruct your study staff to pay particular attention to this distinction for these local adverse events.
- Inconsistency in recording adverse events of special interest. Say you're testing a skin cream, and you want special attention paid to the adverse events of special interest. You may choose to have these signs and symptoms recorded as adverse events. Or, you may choose to have them recorded elsewhere, and only reported as adverse events if they require intervention. Whatever method you choose, try to avoid collecting redundant data, which almost always leads to inconsistencies. Clearly describe where and how these adverse events will be elicited and recorded, and what terminology will be used. Monitor your study sites to ensure compliance with your chosen method.
- Use of slang instead of appropriate medical terminology. For example, a study site may record a verbatim term of "blue". Is this subject sad or depressed, or is he cyanotic? Pay attention to and ask for clarification of vague or ambiguous verbatim terms.
Avoiding these three common mistakes helps reduce confusion, queries, and delay in locking your database and reporting your study results.