STUDY SCIENTIFIC OVERSIGHT Sample Clauses

STUDY SCIENTIFIC OVERSIGHT. A Scientific Steering Committee (SSC) composed of international experts in primary and secondary HLH has been involved in the preparation of study design and protocol writing. This SSC has also been consulted for the composition of the DMC, the selection of its members and the elaboration of the DMC Charter (see Section 9.5.1). The SSC will continue to play an advisory role throughout the course of the study and will perform evaluations of the results for the Sponsor as well as for the DMC. Please refer to Appendix D for full details of membership of the SSC. The DMC, composed of relevant experts (2 pediatric onco-hematologists, 2 pediatric immunodeficiency/infectious disease specialists, a bio-statistician and a specialist in ethics), will oversee the study conduct and evaluate safety and relevant efficacy parameters. See Section 9.5.1 for further details of the DMC.
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