Table 1 Recommendations for managing serious adverse event reporting procedures in palliative care non-pharmacological trials

• Factor in adequate time at the study planning stage to develop serious adverse event reporting procedures especially in a multi-national study or for research naïve settings such as a nursing home.

• Review level of trial oversight required (see Fig. 1)

• Define what a serious adverse event is in your trial, based on your study population, including their health state, the expected risks and the type of events that should be reported.

• Develop documentation to support serious adverse event reporting.

• Implement serious adverse event reporting procedures.

• Monitor serious adverse events during the trial.

• Refine the reporting procedures during the trial if necessary.

• Report the serious adverse events that occur during the trial in the final report papers.