Regulations for Good Clinical Practice Article 106

The investigator shall immediately report any serious adverse events to the sponsor, and shall provide detailed, written reports as soon as possible. The investigator shall immediately report any suspected unexpected serious adverse drug reactions to the Ethics Committee. However, those SAEs that the protocol or other document identifies as not needing immediate reporting shall not apply.The sponsor shall report any suspected unexpected serious adverse reactions that are fatal or life-threatening to the Competent Authority or the contracted organization within 7 days after being aware of the event, and shall provide detailed written documents within 15 days after being aware of the event.The sponsor shall report all the other suspected unexpected serious adverse reactions to the Competent Authority or the contracted organization and provide detailed written documents within 15 days after being aware of the event.The subjects’ identity should be coded in the oral and written reports mentioned in paragraph 1 that should not reveal subjects’ names, ID numbers, addresses, or any other information which may reveal subject’s personal identity.The serious adverse events and serious adverse drug reactions are defined and announced by the Competent Authority.