Reproductive Medicine Collaborative Clinical Trials Program (Collaborative R01 Clinical Trial Required)

[Concept listed as CONCEPT-19-00 0. ] The NICHD invites applications from investigators to participate in a multi-site program designed to conduct clinical trials to investigate problems in reproductive medicine, female and male infertility, and gynecologic and male reproductive system diseases and


disorders that impact fertility.

This funding opportunity announcement (FOA) is intended to support multi-site clinical research consortia devoted to evaluating safety and efficacy of new medications, treatments and technologies addressing questions in infertility.

The objective of this program is to advance scientific research that facilitates diagnostic and therapeutic solutions to infertility by using common protocols in large scale human trials to obtain answers more rapidly than individual sites acting alone.

This program benefits the public:
infertile couples, individuals with reproductive diseases and disorders, and their health care providers.

This FOA supports trials that require participation of two or more collaborative sites for completion of the study.

Accordingly, the collaborating sites share a specific protocol across the sites and are organized to increase sample size, accelerate recruitment, or increase sample diversity and representation.

Each site has its own Program Director/Principle Investigator (PD/PI) and each consortium includes a mechanism for coordination, implementation and monitoring of the protocol across sites, quality control, database management, statistical analysis, and reporting.
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Department of Health and Human Services

Agency: Department of Health and Human Services

Office: National Institutes of Health

Estimated Funding: $4,100,000

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Additional Information of Eligibility:
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U. S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U. S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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