Acuerdo de Investigación no Intervencionista entre Fundación Manuel Pérez y Merck Sharp & Dohme LLC

Abstract

The Institution and Principal Investigator (named in Article 2 below) shall perform the Study in accordance with the terms of this Agreement and the final protocol including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “Observational, descriptive, prospective, longitudinal study of the characteristics, outcome, and follow-up after hospital discharge of children with pneumonia complicated by pleuropulmonary suppuration and/or pulmonary necrosis” (the "Protocol") MISP Database number 101798, which has been accepted by MSD in writing and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Guideline for Good Clinical Practice and other generally accepted standards of good clinical practice. Institution and Principal Investigator further agree not to conduct any research activities which are contrary to the provisions of the Protocol or outside the scope of the Protocol. Principal Investigator (or Institution) will undertake the Study as the legal sponsor of the Protocol and will fulfill the requisite sponsor duties and obligations in conducting the Study. Institution and Principal Investigator agree that Institution is the sole research site conducting this Study.