Data and Safety Monitoring. Sponsor acknowledges that is has the responsibility to conduct data and safety monitoring. Monitoring will be performed on a regular basis, and conclusions of the Data and Safety monitoring entity reported to the Institution. Recommendations that emanate from monitoring activities will be reviewed by Sponsor and addressed. Sponsor assumes responsibility for informing Institution concerning the data and safety monitoring policy and procedures. Institution will provide feedback to Sponsor on a regular basis, including findings from adverse-event reports, and recommendations derived from data and safety monitoring. Notification of Results Sponsor shall promptly report to Institution any findings from monitoring or safety reporting of this Study or studies using the same or similar Study Drug / Device or treatment regimen, whether ongoing or ended, that could:
Appears in 4 contracts
Samples: Clinical Trial Research Agreement, Research Agreement, Research Agreement
