Spinal Cord Injury Research Program Clinical Trial Award - Rehabilitation — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

Spinal Cord Injury Research Program Clinical Trial Award - Rehabilitation

The Clinical Trial Award – Rehabilitation (CTA-R) supports rapid implementation of clinical trials with the potential to have a significant impact on the understanding of SCI and amelioration of its consequences. All stu...

64
match
Award $0 Deadline 6036 days ago Location Alabama Type grant Level Federal Closed posted Jul 13, 2009
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$9,600,000.
  • Next deadline: December 10, 2009.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
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The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

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Award amount
$0
Deadline
6036 days ago
Dec 10, 2009
Total pool
$9.6M

About this opportunity

The Clinical Trial Award – Rehabilitation (CTA-R) supports rapid implementation of clinical trials with the potential to have a significant impact on the understanding of SCI and amelioration of its consequences. All studies must be focused on rehabilitative aspects of SCI. All studies must also be applicable to the health care needs of the military service members, their family members, and/or the veteran population. Funding from this award mechanism cannot be used for preclinical research studies. Principal Investigators (PIs) seeking funding for a preclinical research project should utilize one of the other applicable FY09 SCIRP award mechanisms (for more information about those mechanisms, see http://cdmrp.army.mil). PIs must clearly specify in the Clinical Protocol (main body of the application) which type of clinical trial is being proposed: Phase 0, Phase I, Phase II, Phase III or a combination. For descriptions of each type of clinical trial, please refer to http://www.clinicaltrials.gov and http://www.fda.gov/cder/guidance/6384dft.htm. In addition, refer to the Application Instructions & General Information, Appendix 6, for helpful information about distinguishing clinical trials and clinical research. The proposed clinical trial is expected to begin within 12 months of the award date. CTA-R applications should: Demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. Describe clearly defined, focused endpoints for the proposed clinical trial that correspond to the design and sample size proposed. DOD Spinal Cord Injury Clinical Trial Award 4 Clearly articulate the statistical analyses plan. Include a power analysis reflecting sample size projections that will clearly answer the objectives of the study. Discuss the potential impact of the study results for patients with the specified disease/condition. 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. The clinical trial should have a potentially high impact. The focus must be clearly on SCI rehabilitation. Investigational New Drug (IND) approvals, if applicable, should be initiated or completed before submission to the CTA-R mechanism. If IND/IDE (investigational device exemption) approval is not received by June 30, 2010, the Government reserves the right to revoke funding. Demonstrate institutional support. Multi-institutional Clinical Trials: If the proposed clinical trial is multi-institutional, plans for communication and data transfer between the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the Clinical Protocol. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials. 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 USAMRMC Office of Research Protections (ORP), Human Research Protection Office (HRPO), in addition to local IRBs. 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 Application Instructions & General Information, Appendix 6, for detailed information.

Funding agency

Defense Health Agency Contracting Activity - DHACA
Federal agency

Tags

Healthcare & Biotech Technology & Software Arts & Culture Education & Research Veterans Transportation & Logistics Science, Tech & Engineering (STEM)
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Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

We don't have application instructions on file yet — head straight to the official source.

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Source documents

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Canonical NOFO, application packet, and forms
No supplemental documents yet.

Direct downloads (NOFO PDFs, application forms, FAQs) will appear here once our team attaches them. For now, the agency site has the canonical packet.

Citation details

Source systemgrants.gov
Source ID48414
PostedJul 13, 2009

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