DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award

The PRORP CTRA mechanism was first offered in FY16. Since then, 44 CTRA applications have been received, and 8 have been recommended for funding. The PRORP CTRA is intended to support high-impact and/or new/emerging clin...

81
match
Deadline 2467 days ago Location Alabama Type grant Level Federal Closed posted May 16, 2019
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$6,000,000.
  • Next deadline: September 18, 2019.
  • 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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Deadline
2467 days ago
Sep 18, 2019
Total pool
$6M

About this opportunity

The PRORP CTRA mechanism was first offered in FY16. Since then, 44 CTRA applications have been received, and 8 have been recommended for funding. The PRORP CTRA is intended to support high-impact and/or new/emerging clinical research that may or may not be ready for a full-scale randomized controlled clinical trial. Projects should demonstrate potential to impact the standard of care, both immediate and long-term, as well as contribute to evidence-based guidelines for the evaluation and care of all patients with orthopaedic injuries.  One goal of the FY19 PRORP CTRA is to translate current and emerging techniques and interventions into the clinical space to better serve military patients closer to the point of injury and in a delayed evacuation scenario. The health, functional abilities, and quality of life of individuals who have sustained an orthopaedic injury should be considered.  Another goal is to identify the most effective prevention options available to support critical decision-making for caregivers, and policymakers. The FY19 PRORP CTRA differs from the FY19 PRORP Clinical Trial Award (CTA) in that the CTRA allows for clinical research projects, whereas the CTA is restricted to clinical trials only. Funding from this award mechanism must support clinical research; animal research is not allowed. The proposed studies may be interventional and may involve some retrospective data analysis. Note that purely retrospective or database-related research is not allowed under this funding opportunity. Small pilot clinical trials with human subjects are also allowable. New FY19 definition: A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/ If the proposed research includes the use of a drug that has not been approved by the Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required. It is the responsibility of the applicant to provide evidence from the Institutional Review Board (IRB) of record or the FDA if an IND is not required. If an IND is required, the IND application must be submitted to the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ If the investigational product is a device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IDE is not required, or if the device qualifies for an abbreviated IDE. If an IDE is required, the IDE application must be submitted to the FDA within 12 months of the award date. The IDE should be specific for the device ( should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial. Refer to Attachment 8: Regulatory Strategy, for additional details on documentation of FDA applications. The Government reserves the right to withdraw funding if an IND or IDE application and/or international regulatory application is necessary but has not been submitted within 12 months of the award date.

Funding agency

Defense Health Agency Contracting Activity - DHACA
Federal agency

Tags

Healthcare & Biotech Manufacturing Arts & Culture Education & Research Veterans Transportation & Logistics
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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

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Source documents

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Canonical NOFO, application packet, and forms
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Citation details

Source systemgrants.gov
Source ID316050
PostedMay 16, 2019

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