Adverse event reporting and harms {22}
ADVERSE EVENTS, ADVERSE EVENT, EVENT, ADVERSE EVENT, ADVERSE REACTION
Adverse events of special interest and serious adverse events, whether related or unrelated, will be reported to the sponsor within 24 h using the appropriate expedited report form. Other supporting documentation of the event may be requested by the sponsor and should be provided as soon as possible. New information regarding the adverse events of special interest or serious adverse events, if not mentioned in the first report, will be sent to the sponsor by the principal investigator. This report will be submitted spontaneously as soon as new elements are known.A serious adverse event considered completely unrelated to another previously reported serious adverse event will be reported separately as a new incident.Serious adverse event reports will be archived in the Investigator Site File.The sponsor will be responsible for notifying the regulatory authority and ethics committee of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than 7 calendar days after the sponsor's initial receipt of the information. The sponsor will notify the regulatory authority and ethics committee of any other suspected unexpected serious adverse reaction as soon as possible but in no case later than 15 calendar days after the sponsor's initial receipt of the information.