Common use of Adverse Experiences Clause in Contracts

Adverse Experiences. The investigator agrees to notify POI and/or YM within a maximum of 24 hours (whenever possible immediately by telephone or fax) of any serious (fatal, life threatening, requiring or prolonging hospitalisation, resulting in persistent or significant disability, representing a significant hazard, a congenital anomaly, or other medically important condition) and/or unexpected adverse events. An SAE form with all available information should be submitted within 24 hours to YM and POI. Details should be also noted on the appropriate form in the CRF, followed up and investigated further when necessary. All events should be followed-up until resolution and any new information should be promptly submitted to YM and POI on a follow-up SAE form. The investigator should also notify the local Ethics Committee, within the time frame specified by the Ethics Committee.