VA Form 10-0455: Clinical Trial Annual Progress Report

VA Form 10-0455: Clinical Trial Annual Progress Report – VA researchers and principal investigators conducting clinical trials funded or supported by the U.S. Department of Veterans Affairs (VA) use VA Form 10-0455 to submit required annual progress updates. This form helps ensure accountability, participant safety, and continued funding for studies that improve care for Veterans.

What Is VA Form 10-0455?

VA Form 10-0455, titled Clinical Trial Annual Progress Report, is a standardized document from the Veterans Health Administration (VHA). Revised in June 2007, it captures key details about the status, progress, and challenges of ongoing VA-sponsored or VA-supported clinical trials.

The form typically includes sections for:

  • Project title and ID
  • VA Medical Center and Principal Investigator details
  • Period covered by the report
  • Overall study status (e.g., Not Yet Recruiting, Recruiting, No Longer Recruiting, Completed)
  • Progress summary
  • Enrollment and inclusion data (often linked with the related VA Form 10-0455a)
  • Any issues, deviations, or safety concerns

It supports internal VA oversight, Institutional Review Board (IRB) continuing reviews, and compliance with broader federal requirements.

Who Needs to Submit VA Form 10-0455?

Principal Investigators (PIs) and research teams at VA facilities conducting clinical trials—especially those funded by the VA Office of Research and Development (ORD)—must complete and submit this form annually. It applies to studies involving Veterans as participants and helps fulfill VA’s commitment to transparent, ethical research.

Failure to submit timely progress reports can impact project funding and eligibility for future awards.

Why Is the Clinical Trial Annual Progress Report Important?

Annual reporting serves multiple critical purposes:

  • Participant Safety: Allows ongoing monitoring by IRBs, Data Monitoring Committees, and VA oversight bodies.
  • Funding Accountability: Demonstrates progress to secure continued support from ORD programs.
  • Regulatory Compliance: Supports requirements under FDA regulations (for applicable trials), ClinicalTrials.gov updates, and VA policies.
  • Transparency: Contributes to public knowledge through registries and helps advance Veteran-focused healthcare innovations.

VA emphasizes timely updates, with protocol records on ClinicalTrials.gov needing verification or updates at least every 12 months.

How to Download and Complete VA Form 10-0455?

Download the official fillable PDF here:
VA Form 10-0455 Clinical Trial Annual Progress Report Download PDF

Tips for Completion:

  1. Use the fillable PDF for accuracy.
  2. Provide clear, concise summaries of progress, recruitment, data collection, and any obstacles.
  3. Coordinate with your local VA Research Office or IRB.
  4. Submit via designated channels (often email to [email protected] or through internal VA systems).

Always refer to the latest guidance from your ORD funding program or the ART Program for submission processes.

  • VA Form 10-0455a: Clinical Trial Inclusion/Enrollment Report (often submitted alongside).
  • ClinicalTrials.gov Registration and Results Reporting: Required for ORD-funded trials via the ART Program.
  • VA Office of Research & Development (ORD): Main hub for policies — research.va.gov

For questions, contact:

Best Practices for VA Clinical Trial Compliance

  • Maintain accurate records and update ClinicalTrials.gov promptly.
  • Prepare reports several weeks in advance of deadlines.
  • Document any protocol deviations, adverse events, or enrollment challenges thoroughly.
  • Work closely with your facility’s Research Compliance Officer.

Staying compliant supports VA’s mission to deliver cutting-edge care to America’s Veterans through rigorous, ethical research.

Official Source: VA Form 10-0455 Page Visit VA.gov

This article is for informational purposes only and is based on publicly available VA resources as of 2026. Always verify with official VA channels or your local research office for the most current requirements.