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 shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its LEC reporting obligations. Sponsor will promptly report to the Site, the Institution’s LEC, and Quintiles, 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 LEC approval to continue the Study.
Appears in 3 contracts
Sources: 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. The Site Institution and Investigator shall comply with its LEC EC reporting obligations. Sponsor will promptly report to the SiteInstitution and Investigator, the Institution’s LECEC, and QuintilesCRO, 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 LEC IEC approval to continue the Study.
Appears in 3 contracts
Sources: 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 regulationsApplicable Laws. The Institution acknowledges that the Investigator shall cooperate with Sponsor or its designee in its efforts to follow-up on any adverse events. The Site shall comply with its LEC reporting obligations. Sponsor will promptly report to the Site, the Institution’s LEC, and QuintilesIQVIA, 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 LEC approval to continue the Study.
Appears in 1 contract
Sources: 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 regulationsApplicable Law. The Investigator shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its the applicable LEC reporting obligations. Sponsor will promptly report to the Site, the Institution’s applicable LEC, and Quintiles, 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 InstitutionLEC’s LEC approval to continue the Study.
Appears in 1 contract
Sources: 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 shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its LEC reporting obligations. Sponsor and the Site will promptly report to the Siteeach other, the Institution’s LEC, and QuintilesIQVIA, 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 LEC approval to continue the Study.
Appears in 1 contract
Sources: 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 shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its LEC reporting obligations. Sponsor will promptly report to the Site, the InstitutionSite’s LEC, and Quintiles, 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 InstitutionSite’s LEC approval to continue the Study.
Appears in 1 contract
Sources: 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. The Site Institution and Investigator shall comply with its LEC IRB/EC reporting obligations. Sponsor will promptly report to the SiteInstitution and Investigator, the Institution’s LECIRB/EC, and QuintilesCRO, 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 LEC EC approval to continue the Study.
Appears in 1 contract
Sources: 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 and regulations. The Investigator shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its LEC EC reporting obligations. Sponsor will promptly report to the Site, the Institution’s LECEC, and QuintilesIQVIA, 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 LEC EC approval to continue the Study.
Appears in 1 contract
Sources: 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 Insitution acknowledges thatInvestigator shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its LEC reporting obligations. Sponsor will promptly report to the Site, the Institution’s LEC, and QuintilesIQVIA, 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 LEC approval to continue the Study.
Appears in 1 contract
Sources: 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 shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its LEC reporting obligations. Sponsor will promptly report to the Site, the Institution’s LEC, and Quintiles, 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 LEC approval to continue the Studyúdaje” zůstane závazný i v případě zániku platnosti či vypršení platnosti této Smlouvy.
Appears in 1 contract
Sources: Clinical Trial Agreement