Adverse Events. The Investigator shall report adverse events and serious adverse events as directed in the Protocol and by Applicable Laws and regulations. The Investigator and Institution shall cooperate with Sponsor in its efforts to follow-up on any adverse events. Institution and Investigator shall comply with its EC reporting obligations. Sponsor will promptly report to the Institution and Investigator, the Institution’s EC, and CRO, any finding that could affect the safety of participants or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the Institution’s IEC approval to continue the Study.
Appears in 3 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Adverse Events. The Investigator shall report adverse events and serious adverse events as directed in the Protocol and by Applicable Laws applicable laws and regulations. The Investigator and Institution shall cooperate with Sponsor in its efforts to follow-up on any adverse events. Institution and Investigator The Site shall comply with its EC LEC reporting obligations. Sponsor will promptly report to the Institution and InvestigatorSite, the Institution’s ECLEC, and CROQuintiles, any finding that could affect the safety of participants or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the Institution’s IEC LEC approval to continue the Study.
Appears in 3 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Adverse Events. The Investigator shall report adverse events and serious adverse events as directed in the Protocol and by Applicable Laws and regulations. The Investigator and Institution shall cooperate with Sponsor in its efforts to follow-up on any adverse events. Institution and Investigator shall comply with its IRB/EC reporting obligations. Sponsor will promptly report to the Institution and Investigator, the Institution’s IRB/EC, and CRO, any finding that could affect the safety of participants or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the Institution’s IEC EC approval to continue the Study.
Appears in 1 contract
Samples: Clinical Trial Agreement
Adverse Events. The Investigator shall report adverse events and serious adverse events as directed in the Protocol and required by Applicable Laws applicable laws and regulations. The Investigator and Institution shall cooperate with Sponsor in its efforts to follow-up on any adverse events. Institution and Investigator The Site shall comply with its EC reporting obligations. Sponsor will promptly report to the Institution and InvestigatorSite, the Institution’s EC, and CROIQVIA, any finding adverse trends that could in its good faith determination would likely affect the safety of participants Study Subjects or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the Institution’s IEC EC approval to continue the Study.
Appears in 1 contract
Samples: Clinical Trial Agreement