7.6 Recognition and Reporting of Adverse Events (AEs)
The DSI must ensure prompt reporting of AEs to the referring tertiary centre. The tertiary centre PI holds the ultimate reporting responsibility to COG, OCREB, and Health Canada.
Description of AEs will be sent from the satellite site to the tertiary site as part of the patient’s source documentation and will be reported to the sponsor (COG) as per the protocol and to OCREB and Health Canada as per their requirements and the tertiary site Standard Operating Procedures (SOPs).
For Severe Adverse Events (SAEs), the satellite site must provide the information and all source documentation available to the tertiary within 24 hours of the event to ensure timely expedited reporting.