Risk minimization measures Sample Clauses

Risk minimization measures. In view of the expected benefits the above listed risks are considered to be manageable in this patient population, if adequate minimization measures are put in place. An overview of specific measures to minimize the subject’s risk is provided below: • Study designed with HLH experts forming the SSC • Patients are hospitalized in specialized centers for the treatment of HLH, and therefore with all necessary emergency assistance equipment • Inclusion/exclusion criteria: patients with malformations or severely altered functions (either due to the disease stage or to a concomitant disease), as well as patients with evidence of patent or latent TB infections or active mycobacteria, Shigella, Salmonella, Campylobacter or Leishmania infections, will not be included in the study (for details see Section 4.1) • Infusion Related Reaction (IRR) monitoring: patients will be very closely monitored during the study drug infusions and for 24 hours following them to immediately identify if the subject is experiencing any IRRs. Each of the specialized centers will have physicians adequately trained in IRR management (please see NI-0501-04 Study Specific Risk Management Plan for further details). • Recommendations on prophylaxis for Pneumocystis jiroveci, fungal infections, Herpes Zoster virus for all patients and Tuberculosis for a defined subpopulation (see section 6.2) in the protocol to avoid occurrence of these infections • Close monitoring of potential infections through careful physical examination, laboratory parameters, active search for EBV, CMV, Adenoviruses, detection of tuberculosis • Study safety surveillance by a Data Monitoring Committee The Development Risk Management Plan addresses risks, identify signals for early detection of safety concerns and propose mitigating actions. It will be part of the study documentation shared with Investigators and any relevant third party involved in the study. Stopping rules have been also developed to ensure individual patient safety and determine whether the study should be put on hold or terminated prematurely.