This application is in response to RFA-HD-06-008 to establish a Data Coordination Center (DCC) as a part of the Cooperative Multicenter Reproductive Medicine Network (RMN). As requested by the RFA, we will be responsible for study design, central database management, statistical leadership;and coordination of the administrative activities of the Network including organizational, informational, logistic, regulatory support to the RMN in order to conduct the clinical trials on treatments for reproductive disorders. As a part of the RMN, we will participate in a cooperative manner with and provide vital support to the Clinical Sites and the NICHD in all aspects of Network research as outlined in this RFA. For example, we will communicate regularly with and report timely to the NICHD Program Administrators, the Steering Committee (SC), the Data Safety and Monitoring Committee (DSMC), the Network investigators;will arrange RMN related meetings and conference calls;will prepare and distribute meeting agendas, minutes, and action items for the RMN committee and DSMC meetings and calls, site visits, track samples;will monitor adverse events, conduct site visits, assist RMN with regulatory requirements;and will provide timelines for the completion of action items and updates on the status of action items as required. We will collaborate with investigators in RMN in the protocol development, participate in the committees including the SC, and interact with other sites, the Advisory Committee (AC), and the DSMC. We have assembled a team of outstanding investigators with extensive experience in all of areas of the DCC and RMN, and several investigators are collaborating with the PI in providing the similar support for the Genomic and Proteomic Network for Preterm Birth Research funded by the NICHD. We have the best facilities and information technologies. We are determined to strengthen our partnership with the NICHD and are ready to establish new partnerships with clinical research sites in the RMN in this important joint effort to conduct clinical trials for reproductive disorders. We are committed to the role and responsibilities of the DCC as stated in the RFA and have full institutional support in this endeavor.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD055925-04
Application #
8005708
Study Section
Special Emphasis Panel (ZHD1-DSR-A (08))
Program Officer
De Paolo, Louis V
Project Start
2007-08-24
Project End
2012-11-30
Budget Start
2010-12-01
Budget End
2011-11-30
Support Year
4
Fiscal Year
2011
Total Cost
$2,324,928
Indirect Cost
Name
Yale University
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
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Diamond, Michael P; Legro, Richard S; Coutifaris, Christos et al. (2015) Letrozole, Gonadotropin, or Clomiphene for Unexplained Infertility. N Engl J Med 373:1230-40
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