Adverse event reporting and harms
ADVERSE EVENTS, EVENT, EVENTS
Harm to participants in this trial is very unlikely. In that event, women are eligible to apply for compensation from the national Accident Compensation Corporation, just as if they would be if injured in an accident, at work or at home. This study uses the national Health and Disability Ethics Committee (HDEC) definitions for serious adverse events, protocol deviations, and protocol violations. Events meeting these definitions will be reported to the DMC and the HDEC, along with the actions taken in response to any event.