Data Monitoring Committee and Study Pausing and Stopping Rules Sample Clauses

Data Monitoring Committee and Study Pausing and Stopping Rules. A data monitoring committee (DMC) will be appointed to review the study data and make recommendations concerning the continuation, modification, or termination of the study as detailed in Section 5.1.4. The following study pausing or holding rules will apply for the study: 1. One or more study treatment-related SAE(s) or study treatment-related AESI occurs. 2. Anaphylaxis or bronchospasm occur within 4 hours of vaccination, indicative of an immediate hypersensitivity reaction to vaccination.
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