Responsibilities of the Independent Safety Monitoring Board Sample Clauses

Responsibilities of the Independent Safety Monitoring Board. An Independent Safety Monitoring Board (ISMB) will be established prior to the start of the study to monitor the safety of BL-1040 during the conduct of the protocol. This ISMB will consist of physicians with expertise in cardiovascular disease, particularly in the area of coronary artery disease and with experience monitoring safety of drugs and/or devices for cardiovascular applications, and will have no participation in the trial in any other capacity. The ISMB will ensure that this study meets the highest standards of patient safety. During the study the ISMB will have the following main responsibilities: · review 30 day safety data patients from the first 2 sequentially enrolled patients to determine whether 3 additional patients may be enrolled: after reviewing the 30 day safety data from these 3 patients, will determine whether the balance of patients may be enrolled · within 30 days of enrolment of each successive group of 5 patients receiving the device, will review all SAEs occurring to date and will recommend continuation, discontinuation, or modification of the procedure or protocol, based on a determination of whether the occurrence of serious, unexpected, or device-related adverse events (Sec. 7) might outweigh the potential benefit achievable with the device · review emerging findings in patients and identify potential safety concerns with BL-1040 · will receive information, on an expedited basis, on all Serious Adverse Events (SAEs), clinically significant laboratory values/xxxxx xxxxx, ECG abnormalities and data from patients who decided to prematurely discontinue the study. All SAES that occur in the cath lab during or after the procedure to administer BL-1040 should be reviewed promptly by the ISMB. The ISMB will review this information and may decide to interrupt, alter, or terminate the trial · will adjudicate whether or not an event is unexpected, based on a pre-specified list of expected SAEs within the study population.
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