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UW ClinicalTrials.gov Service

UW ClinicalTrials.gov Service

The UW has a central ClinicalTrials.gov (CT.gov) service to assist PI’s and study teams with CT.gov registration, maintenance, and results reporting processes.

 

This service is free of charge to study teams who would like assistance.

 

To get started:

 

 

 

 

 

The UW CT.gov Service was established in 2018 with the initial goal of bringing UW CT.gov records into compliance with legal requirements and to create proactive processes for maintaining public record compliance going forward. However, UW Investigators conducting clinical trials are driven by a greater purpose of meeting an ethical obligation to trial participants and to be in service to the community at large. UW CT.gov Specialists share this commitment and approach public clinical trial records with Investigator integrity in mind.

What is ClinicalTrials.gov?

ClinicalTrials.gov is an online clinical study registry and results database for participants, their families, health-care professionals, researchers, policy makers, and the public to access information about research studies involving human volunteers. This public resource has evolved with various stakeholder perspectives in mind.

Participant Perspective
  • Registration to the public provides information to potential participants & referring clinicians about potentially life-saving treatments

 

  • Transparency in clinical trial information fulfills an ethical obligation to participants in research that they volunteer to take part in

 

  • Access to study protocols and statistical analysis plans helps all stakeholders understand the context of study results

 

  • Dynamic records show when study sites are recruiting
General Public Perspective

The general public holds within it the pool of future participants.

 

  • Public clinical trials records promote scientific integrity and transparency

 

  • Transparency, communication, and priority to meet ethical obligations builds trust between researchers and under-represented communities

 

  • Provides a mechanism to demonstrate the responsible allocation of government funds, which are ultimately derived from the citizenry
Researcher Perspective
  • Public clinical trials records enhance study recruitment

 

    • Dynamic records show when study sites are recruiting

 

    • Protocol records indicate participant populations of interest

 

    • CT.gov public site provides source data for clinical trials search engines

 

  • Summary results reduce publication bias, provide new data of interest quickly, and facilitate new research collaboration

 

  • Results Module provides several places to ‘show your work’ in service to the research community. Why was an outcome measure not measurable per protocol? What were barriers to study completion? What limitations and caveats are there to reported results? Who can researchers contact to learn more from your efforts?
Research Community

Ultimately in the interest of policy makers and the general public.

 

  • Availability of summary results and de-identified individual participant data enables leverage of existing volunteer efforts, providing data for additional IRB-approved study, and the opportunity to turn data derived from participant-volunteers in underpowered trials into meaningful results

 

  • Promote efficient allocation of research funds

 

  • Clarity around the scope of clinical trials already conducted helps researchers avoid duplicative efforts

 

  • Provide a public mechanism to identify and understand the evidence base for specific biomedical questions
Policy Makers
  • Understanding the full list of clinical trials conducted and the data collected provides policy makers with data to make the most informed decisions

 

  • Provides a central catalog of research addressing public health issues; ie COVID-19 pandemic
Video Tutorials

ClinicalTrials.gov Annual Verification
Learn how to complete annual verification of your ClinicalTrials.gov record.

 

Updating PRS Study Status
Learn how to login to ClinicalTrials.gov’s Protocol Registration and Results System

 

Uploading Documents
Learn how to prepare the final protocol with statistical analysis plan to satisfy results reporting requirements or an informed consent form as required by the revised common rule for upload to ClinicalTrials.gov, and to login to the Protocol Registration and Results System, or PRS, to upload study documents.

News

Click Here to read news items and updates related to ClinicalTrials.gov.

CT.gov PRS Website

A CT.gov Protocol Registration and Results System (PRS) user account is required to register your clinical study to ClinicalTrials.gov. The CT.gov PRS is the data entry portal for initial registration and to make subsequent updates to trial records on the public ClinicalTrials.gov site.

 

 

Frequently Asked Questions

Learn more about the UW ClinicalTrials.gov Service, our processes, and the services that we offer.

Feedback Survey

Access this brief survey to provide feedback about our CT.gov service.

Questions?

Email

608.265.3132

CT.GOV SPECIALISTS

Meredith Rhodes

MEREDITH RHODES

Meredith Rhodes has been a UW CT.gov PRS Admin since 2017 and has served in leadership on the National CT.gov Taskforce since 2020. She is driven to see UW lead in clinical trials transparency by our ethical obligation to participants and our service to the scientific community. Meredith is a student of the Earth and enjoys contemplating how our environment shapes us.

Celia Westemeier

CELIA WESTEMEIER

Celia Westemeier has worked as a Regulatory Specialist for the UW since 2016. She is committed to her community, volunteering with Neighbors Helping Neighbors and serving in various leadership roles at her church. Celia has a taste for fine foods and appreciates the arts and cultural experiences that Madison offers.