Data Coordination Center for the RMN

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DESCRIPTION (provided by applicant): In response to RFA-HD-14-018, we are re-competing for the Data Coordination Center (DCC) as a part of the Cooperative Multicenter Reproductive Medicine Network (RMN) and will be responsible for Study Design, Conduct, Analyses and Publications; Data Management; Site Monitoring; Regulatory Requirements; and Financial Administration as a continuation of our current work. We will participate in a highly cooperative manner and provide vital support to the Clinical Sites and the NICHD in all aspects of the RMN. For example, we will communicate regularly with and report in a timely manner to the NICHD Program Administrators, Steering Committee (SC), Data and Safety Monitoring Board (DSMB), Advisory Board (AB) and RMN investigators; actively participate in all aspects of protocol development; arrange logistics for RMN-related meetings and teleconferences; prepare and distribute meeting and teleconference agendas, minutes, and action items for the RMN committees and boards; conduct site monitoring visits; oversee biospecimen management; monitor adverse events; assist RMN with regulatory requirements; collaborate with study drug and biorepository representatives; provide or coordinate training for study personnel; facilitate data and resource sharing and retrieve the data generated from the RMN samples used by outside investigators; perform data quality control, analysis and reporting; manage the protocol-related costs; and most importantly, initiate and/or collaborate in scientific publications. The RMN has experienced unprecedented productivity, exceeding our goals in many areas. As a key contributor to this success, our DCC "stands tall with the best of the best." The RMN has greatly enjoyed and benefited from our presence and contribution, and vice versa. We have full support from our institution, including world renowned facilities and information technology. We are determined to advance the RMN and NICHD mission for improving infertility treatment, and more broadly, public health policy and practice.