VENN LIFE SCIENCES AG ROLE & RESPONSIBILITIES Sample Clauses

VENN LIFE SCIENCES AG ROLE & RESPONSIBILITIES. Venn Life Sciences AG will provide coordinating services for the study. The ISMB Coordinator will provide information, on an expedited basis, on all Serious and Severe Adverse Events, clinically significant laboratory values (as defined in the study safety plan, ECG abnormalities and xxxxx xxxxx that are associated with Serious and Severe Adverse Events as required, to the ISMB members. Venn Life Sciences AG will be charged with the following responsibilities: · To identify a specific individual to interface with the ISMB. · To provide all required information in advance of the meeting in a mutually agreeable format approved at the initial meeting of the ISMB. · To provide a standard safety narrative for all patients who withdraw from the study due to Serious or Severe Adverse Events. · To provide specific meeting issues in advance of the meeting. · To keep the ISMB Chairman informed of any serious safety issues as the study progresses · To inform each principal investigator of the ISMB recommendations, as required. · To notify Bioline Innovations Jerusalem of any issues related to the ISMB which might negatively influence the study.
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