Office of Research & Development

ORD Sponsored Clinical Trials: Registration and Submission of Summary Results

Access to clinical trials is critical for VA's ability to advance knowledge and care for Veterans and the nation. The VHA Office of Research and Development (ORD) is committed to informing Veterans and the public about its research and maximizing the impact of the studies it supports. As a leader in clinical trials access, ORD has been making clinical trial information available through public registries for more than a decade. To achieve these goals, Principal Investigators (PIs) of ORD funded clinical trials are responsible for registering their trials with and submitting summary results to the National Library of Medicine's (NLM) public registry, ClinicalTrials.gov, as a condition of funding. ClinicalTrials.gov provides patients, family members, health care professionals and members of the public easy access to information on clinical trials for a wide range of diseases, conditions and health problems.

ORD uses the same definition of a clinical trial as the International Committee of Medical Journal Editors (ICMJE) and the World Health Organization. This definition is "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." VA PIs should note that by applying this definition and registering a clinical trial prior to enrollment of the first participant, the trial will be eligible for publication in ICMJE member journals and other journals that follow the ICMJE requirements. (For more information, see http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html and/or N Engl J Med 2004;351:1250-1.) For the subset of VA clinical trials that fall under Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), registration at ClinicalTrials.gov will also help meet those requirements specified in the law.

Upon notification of funding approval, VA PIs must register their clinical trials in ClinicalTrials.gov through ORD mechanisms. Meeting this requirement allows for study funds to be distributed from ORD. Subsequently, PIs are also responsible for providing regular updates on the study and ensuring results are reported.

Information for VA ORD Funded Investigators

ORD clinical trial PIs are responsible for all aspects of registering, updating, and reporting results of their studies in ClinicalTrials.gov. To assist investigators in meeting these requirements, ORD has standardized some processes through HSR&D's ART Program (ART Website: http://art.puget-sound.med.va.gov). Please note that some steps require direct interaction with the ClinicalTrials.gov system and staff.

Registration Process

VA investigators funded by any ORD research service (Clinical Science, Health Services, and Rehabilitation) must have their clinical trial registered as a condition of award. Cooperative Studies Program (CSP) clinical trials are registered through the CSP Coordinating Center. Investigators are notified of the requirement at the time of award. When all other Just-In-Time (JIT) system requirements are completed, investigators are contacted by the ART Program and provided instructions for registering their clinical trial.

Overview of steps involved in clinical trial registration:

  1. The funding ORD Service initiates the process by entering the requirement for clinical trial registration in the JIT system. This action notifies the ART Program that a clinical trial has been approved for funding.
    • Note that CSP notifies the ART Program directly of any new clinical trials.
  2. ART emails the PI with instructions for accessing the ART Intranet site and completing the data collection form. You must be logged into the VA network in order to access the ART Intranet site.
    • If you do not have access to the VA network, please contact the appropriate ORD Service contact below.
    • If you would like to designate a project staff member to complete data entry on your behalf, contact the ART Program at art@va.gov. However, please note that the PI remains ultimately responsible for the contents/information provided.
  3. The PI (or project staff member) completes the clinical trial information on the ART Intranet site and submits it.
  4. The ART Program uploads the information to ClinicalTrials.gov. When registration is complete, ART emails proof of registration (PDF file) to the PI.
  5. Through an automated process, ART sends notification to the JIT system that the registration has been completed. The funding ORD service reviews the registration and approves the component in JIT.
    • For CSP trials, ART notifies the CSP Center of the successful registration.

Registration Update Process

To keep the clinical trial information current for the public and to meet ClinicalTrials.gov requirements for maintaining records, registration records must be updated or verified as correct at least every six months. PIs must also update the record within 30 days of a change to any of the following: overall recruitment status, recruitment status at any study site, and the last follow-up date for the primary outcome measure (e.g., primary completion date).

The ART Program sends an automated email reminder to the PI when a six-month update is due. Updates, like registrations, are completed using the ART Website. Updates are required every six months until the study is completed. Failure to provide updates in a timely manner will impact project funding. The funding ORD service is notified of trials overdue for an update.

Results Submission Process

PIs of ORD funded clinical trials must submit summary results for their clinical trials to ClinicalTrials.gov. This requirement applies to all ORD trials regardless of whether the trial meets the definition of an "Applicable Clinical Trial" as described in Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801). Results information must be submitted within one year of the study Primary Completion Date. This date is the one specified by the PI regarding when the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome. Results information includes Participant Flow, Baseline Characteristics, all pre-specified Primary and Secondary Outcomes, and Adverse Events.

To facilitate investigators in meeting these requirements, ORD notifies the PI by an ART Program email prior to the due date. Instructions for submitting results through the ClinicalTrials.gov Protocol Registration and Results System (PRS) are provided. Please note that ClinicalTrials.gov staff members are available to provide one-on-one assistance to investigators throughout the results submission process. This includes helping investigators prepare for submission, orienting investigators to the PRS and guiding investigators through the data entry process. To schedule an introductory call with ClinicalTrials.gov staff or otherwise request help, send an email to register@clinicaltrials.gov with the request.

Overview of steps for clinical trial results submission:

  1. The PI prepares results data for submission.
  2. ART grants the PI permissions to edit the trial record in the PRS and sends an email with login instructions. The ClinicalTrials.gov PRS is accessed at https://register.clinicaltrials.gov.
  3. The PI or designee enters results in the PRS.
    • If assistance is needed at any time during results data entry, please contact ClinicalTrials.gov staff at register@clinicaltrials.gov.
  4. When data entry is complete, the PI sets the record status to "Entry Completed".
  5. The ART Program then releases the record for review by ClinicalTrials.gov staff.
    • A ClinicalTrials.gov staff member will review the study record after it is released (submitted) and before it is posted on ClinicalTrials.gov. This review focuses on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting.
  6. Upon completion of the review, the PI will receive notification from ClinicalTrials.gov that the results have been accepted or additional changes are required. If changes are required, the PI must return to the PRS, address the PRS Review Comments, and mark the record status as "Entry Completed". ART will then release the record for review by ClinicalTrials.gov staff.
    • If there are questions about the comments, it is recommended that you contact ClinicalTrials.gov staff at register@clinicaltrials.gov to request clarification and/or assistance in resolving the comments.
  7. Once accepted, results are posted to the ClinicalTrials.gov website.
  8. Depending on study design and other factors, the PI may need to enter additional results data at a later date.

ORD Clinical Trials Points of Contact

Further questions concerning individual ORD Service trial registration, results reporting or policies can be directed to the following points of contact:

Clinical Science Research & Development Service
Kristina Nord, MSW
Health Science Specialist
Phone: (202) 443-5614
Email: Kristina.Nord@va.gov

Health Services Research & Development
Liza Catucci
Administrative Officer
Phone (202) 443-5797
E-mail: liza.catucci@va.gov

Rehabilitation Research & Development Service
Tiffany Asqueri, MBA
Program Analysis and Review Section Administrator
Phone: (202) 443-5757
Email: tiffany.asqueri@va.gov

Cooperative Studies Program
Grant Huang, MPH, PhD
Acting Director, CSP
Chair, ORD Clinical Trials Registration & Results Work Group
Phone: (202) 443-5700
Email: CSP@va.gov

(Study Chairs may also contact their CSP Coordinating Center.)

ART Program Contact

Questions concerning the ART Website or PRS access can be directed to:
Jolie Bergman
Coordinator, ART Program
Phone: (206) 277-4163
E-mail: ART@va.gov


Questions about the R&D website? Email the Web Team.

Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.