ClinicalTrials.gov Support

ClinicalTrials.gov is a web-based resource for public-facing information on research studies, both clinical trials which are interventional in nature and observational studies. It is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) and supports laws, regulations, and policies that require sponsors and investigators to publicly share information about clinical trials.

The website is made up of records, identified by unique National Clinical Trial (NCT) numbers, that can be searched and viewed by the public. Each record contains multiple components including funding source, study location(s), contacts, eligibility criteria, outcome measures, and study documents such as the protocol, consent form, and statistical analysis plan. Most records are required to submit results. 

For additional information, see the CWRU ClinicalTrials.gov FAQs or review the guidance and resources below. 

ClinicalTrials.gov Guidance and Resources

These guidance documents are meant to serve as a tool for faculty, staff, and students who need to register, maintain, and report results in records on the ClinicalTrials.gov website. For direct help, please contact the CWRU Quality Improvement Program at irbqip@case.edu.

CWRU Policies and Resources

• CWRU Investigator Manual (Chapter 26)
• CWRU ClinicalTrials.gov Registration Requirements
• CWRU Example Interventional Study Template
• CWRU ClinicalTrials.gov Study Registration Guide

ClinicalTrials.gov Protocol Registration System (PRS) Help and Tutorials

• PRS Beginning a Registration Tutorial
• Protocol Registration Data Element Definitions
• Protocol Registration Quality Control Review Criteria
• PRS Preparing to Enter Results Tutorial
• PRS Help: Results Data Entry
• Results Data Element Definitions
• Results Quality Control Review Criteria
• Uploading Study Documents

Get in Touch

If you have any questions, please contact our team.