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. For example, did the skin rash occur at the site of skin cream application, or was it on some distant part of the body? Was the puncture site swelling at the site of drug infusion, or was it on the phlebotomy arm? 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 application site rash, application site pruritus, and application site pain. You may choose to have these signs and symptoms recorded as adverse events. Or, you may choose to have them recorded elsewhere (such as a special page or screen of your case report form). 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 the chosen method for reporting these adverse events.
- 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? 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.