In accordance with Sections 4.1 and 4.3 of these guidelines, the investigator must ensure the safety of the trial subjects. This includes providing the best possible care for subjects experiencing any trial-related adverse events and conducting a thorough investigation to determine causality.
The occurrence of adverse events must be monitored carefully and recorded in detail during the course of the clinical trial.
The trial protocol should clearly state the method(s) by which adverse events will be monitored. Provisions should be included to ensure prompt dose reduction or withdrawal of therapy for patients experiencing unacceptable toxic effects. The protocol should describe how information relating to adverse events is to be handled and analysed by the investigator and sponsor, and their responsibilities to report to each other and to the drug regulatory authority. The sponsor should provide special forms for reporting trial-related adverse events.
Consideration should be given to establishing a special committee to monitor adverse events (see also Section 13).