Section 28: Notification of serious adverse event or reaction

28. Notification of serious adverse event or reaction (1) An investigator shall, within 24 hours of becoming aware of a serious adverse event or serious adverse reaction, inform the sponsor of the event or reaction. (2) Where the sponsor receives information under subsection (1), it shall, within 24 hours, notify the Council and Pharmacovigilance Committee in writing of the serious adverse event or serious adverse reaction. (3) A sponsor shall provide such follow-up information relating to the serious adverse event or serious adverse reaction as the Council or Pharmacovigilance Committee may require. PART IX – REGISTER OF CLINICAL TRIALS (Part IX came into operation on 24 September 2011.)