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 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...

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Deadline 1744 days ago Location Alabama Type grant Level Federal Closed posted Apr 1, 2021
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$7,500,000.
  • Next deadline: September 10, 2021.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
How was this generated?

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.

AI-generated. Always verify with the official source.

Deadline
1744 days ago
Sep 10, 2021
Total pool
$7.5M

About this opportunity

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 FY21 PRORP CTRA is to translate current and emerging techniques and interventions into the clinical space to better serve military patients. 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 FY21 PRORP CTRA differs from the FY21 PRORP Clinical Trial Award (CTA) in that the CTRA allows for clinical research projects, whereas the CTA is restricted to clinical trials only. Applications to the FY21 PRORP Clinical Translational Research Award mechanism must support clinical research and may not be used for animal research. 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 allowable.Clinical research is defined as: (1) patient-oriented research. Research conducted with human subjects (or on material of human origin such as cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Note: Studies that meet the requirements for Institutional Review Board (IRB) review Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.A clinical trial is defined as 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.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 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 FDA within 12 months of the award date. The IND should be specific for the product ( 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 study. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm.If the proposed research includes the use of an investigational device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required.

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Who can apply

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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

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Citation details

Source systemgrants.gov
Source ID332532
PostedApr 1, 2021

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