Adverse event identification, documentation, and reporting

The manuals converge on active, repeated adverse event elicitation across the participant journey. They recommend asking about symptoms at each contact, using non-leading or specific questioning, recording observed and spontaneously reported events promptly, and following unresolved events until resolution, stabilisation, or a satisfactory explanation. They also converge on documenting core fields such as onset, severity, relatedness or causality, outcome, and any action taken, with serious events escalated within protocol timelines. The sources differ mainly in how they frame classification and reporting pathways. Some emphasise source records, legal health records, CRFs, adverse event logs, or secure databases, while others add sponsor, IRB, DSMB, regulator, medical monitor, or supplier reporting. They also vary in the event types highlighted, with some focusing on psychological distress, some on laboratory or vital sign abnormalities, and others naming special reporting situations such as overdose, misuse, medication error, breastfeeding exposure, pregnancy, or protocol-defined unexpected events. A few manuals also specify coding or grading systems, while others stay at the level of clinical review and prompt communication.