Safety reporting quick reference
Recall the distinctions that prevent safety events from being under-reported or misclassified.
battlecard Do not mix these Severity vs seriousness Classify both; one does not automatically answer the other. Unrelated claim The participant says it is unrelated, so we do not need to report it quickly. A coordinator hears a participant's own explanation for an urgent care visit. Your line We still capture the event and notify the investigator. Relatedness is assessed through the study safety process, not by assumption. Do not let the participant's guess replace investigator assessment. It protects broad capture and role clarity. What minimum facts should you collect first for a possible SAE? Who, what happened, onset date/time,…
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