Opportunity W81XWH-10-ARP-CTA

The summary for the Opportunity W81XWH-10-ARP-CTA grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.
Opportunity W81XWH-10-ARP-CTA: The ARP Clinical Trial Award mechanism was first offered in FY09. Since then, nine Clinical Trial Award applications have been received, and one has been recommended for funding.The ARP Clinical Trial Award supports clinical trials with the potential to have a major impact on the lives of individuals with ASD. Funding from this award mechanism must support a clinical trial. In general, a clinical trial is defined as a prospective accrual of volunteers for a study where an intervention (e.g., device, drug, behavioral, surgical procedure, or other) is tested on human subjects for a measurable outcome. Refer to the General Application Instructions, Appendix 5, for additional information about studies involving human subjects. The proposed clinical trial is expected to begin no later than 12 months after the award date.Clinical Trial Award applications should:- Demonstrate availability of, and access to, a suitable population that will support a meaningful outcome for the study. Discuss how accrual goals will be achieved and how standards of care may impact the study population.- Describe clearly defined, focused endpoints for the proposed clinical trial that correspond to the design and sample size proposed.- Include pharmacokinetic and pharmacodynamic outcomes, if applicable. Clearly articulate the statistical analyses plan. Include a power analysis reflecting sample size projections that will clearly answer the objectives of the study.- Include a study coordinator who will guide the clinical protocol through Institutional Review Board (IRB), Human Subjects Research Review Board (HSRRB), and other regulatory approval processes; coordinate activities from all sites participating in the trial, and coordinate participant accrual.- Demonstrate institutional support.- Discuss the potential impact of the study results for individuals with ASD.If the study is in support of an application to the U.S. Food and Drug Administration, an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) application should be submitted prior to the grant application submission. The Government reserves the right to withdraw funding if an active exemption from marketing approval for the IND or IDE has not been acquired within 6 months of the award date.Preliminary data (may be from outside of the ASD research field), unpublished results from the laboratory of the Principal Investigator (PI), research team, or collaborators named on this application, that is relevant to the proposed research project, is required. Proposals should also be based on a sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.Use of Human Subjects and Human Biological Substances: All Department of Defense (DOD)-funded research involving human subjects and human biological substances must be reviewed and approved by the United States Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), in addition to local IRBs. NOTE: Local IRB approval at the time of submission is NOT required. The HRPO is mandated to comply with specific laws and directives governing all research involving human subjects that is conducted or supported by the DOD. These laws and directives are rigorous and detailed, and will require information in addition to that supplied to the local review board. Allow a minimum of 6 months for regulatory review and approval processes for studies involving human subjects. Refer to the General Application Instructions, Appendix 5, for regulatory requirements.
Federal Grant Title: Opportunity W81XWH-10-ARP-CTA
Federal Agency Name: Dept of the Army USAMRAA
Grant Categories: Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: W81XWH-10-ARP-CTA
Type of Funding: Cooperative Agreement Grant
CFDA Numbers: 12.420
CFDA Descriptions: Military Medical Research and Development
Current Application Deadline: Jul 28, 2010
Original Application Deadline: Jul 28, 2010
Posted Date: Feb 16, 2010
Creation Date: Feb 17, 2010
Archive Date: Aug 27, 2010
Total Program Funding: $3,200,000
Maximum Federal Grant Award: $0
Minimum Federal Grant Award: $0
Expected Number of Awards: 2
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Grant Announcement Contact
PA HELP: 301-619-7079; [email protected] eReceipt HELP: 301-682-5507; [email protected]

CDMRP Help Desk [[email protected]]
Similar Government Grants
BROAD AGENCY ANNOUNCEMENT (BAA) for Extramural Biomedical and Human Performance Research a...
DoD Kidney Cancer, Clinical Consortium Award
DOD Toxic Exposures, Translational Research Award
DOD Toxic Exposures, Investigator-Initiated Research Award
DOD Toxic Exposures, Clinical Trial Award
FY2006 Deployed War Fighter Protection Research Program
Department of Defense (DOD) Fiscal Year 2003 (FY03) Breast Cancer Research Program (BCRP)C...
Department of Defense (DOD) Fiscal Year 2004 (FY04) Breast Cancer Research Program (BCRP) ...
More Grants from the Dept of the Army USAMRAA
BROAD AGENCY ANNOUNCEMENT (BAA) for Extramural Biomedical and Human Performance Research a...
DoD Kidney Cancer, Clinical Consortium Award
DOD Toxic Exposures, Translational Research Award

FederalGrants.com is not endorsed by, or affiliated with, any government agency. Copyright ©2007-2024 FederalGrants.com