Adverse Occurrences. The Investigative Site shall notify PSI and the Sponsor (and the competent Regulatory Agencies if required by law) in writing of any and all: (i) adverse experiences that occur during the Study as soon as possible following discovery of the adverse experience; and (ii) serious adverse experiences that occur during the Study as soon as possible but in no event later than twenty-four (24) hours following the discovery of the adverse event. The foregoing obligation applies to all adverse experiences, whether or not the Investigative Site and/or the Investigator believe such adverse experience to be related to the Investigational Product.
Appears in 1 contract
Sources: Clinical Study Agreement
Adverse Occurrences. The Investigative Site shall notify PSI and the Sponsor (and the competent Regulatory Agencies if required by law) in writing of any and all: (i) adverse experiences that occur during the Study as soon as possible following discovery of the adverse experience; and (ii) serious adverse experiences that occur during the Study as soon as possible but in no event later than twenty-four (24) hours following the discovery of the adverse event. The foregoing obligation applies to all adverse experiences, whether or not the Investigative Site and/or the Investigator believe such adverse experience to be related to the Investigational Product.1.8
Appears in 1 contract
Sources: Clinical Study Agreement