Study Termination. If the Sponsor, an Investigator, or Clinical Study Monitor discovers conditions arising during the study that indicate that the clinical investigation should be halted due to an unacceptable patient risk, the study must be terminated after appropriate consultation between ImmunoGen and the Investigators. In addition, a decision on the part of ImmunoGen to suspend or discontinue development of the study drug may be made at any time. Within 15 days of premature closure, ImmunoGen must notify the competent authorities and IECs/IRBs of any member state where the study is being conducted, providing the reasons for study closure.
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