Adverse Experiences. Each Party shall promptly in accordance with applicable country specific safety regulations/GCP guidelines advise the other Party of any reportable adverse reactions or side effects occurring during the conduct of the Study of which it becomes aware. In the event that any reportable adverse reactions associated with the Study Product indicate the possibility of health hazards, Institution shall notify Sponsor and CRO within twenty-four (24) hours of making the discovery. Institution shall further ensure that Investigator complies with the aforementioned obligations.
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Adverse Experiences. Each Party shall promptly in accordance with the Protocol and applicable country specific safety regulations/GCP guidelines advise the other Party of any reportable adverse reactions or side effects occurring during the conduct of the Study of which it becomes aware. In the event that any reportable adverse reactions associated with the Study Product Drug indicate the possibility of health hazards, Institution Provider and Investigator shall in accordance with the Protocol and applicable law notify Sponsor and CRO within twenty-four (24) hours of making the discovery. Institution shall further ensure that Investigator complies with the aforementioned obligations.
Appears in 1 contract
Samples: Clinical Trial Agreement
Adverse Experiences. Each Party shall promptly in accordance with applicable country specific safety regulations/GCP guidelines advise the other Party of any reportable adverse reactions or side effects occurring during the conduct of the Study of which it becomes aware. In the event that any reportable adverse reactions associated with the Study Product Drug indicate the possibility of health hazards, Institution and Investigator shall notify Sponsor and CRO within twenty-four (24) hours of making the discovery. Institution shall further ensure that Investigator complies with the aforementioned obligations.
Appears in 1 contract
Samples: Clinical Trial Agreement