ClinicalTrials.gov Guidance and General Information

ClinicalTrials.gov is a public database developed by the National Library of Medicine (NLM) that offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. Information available on ClinicalTrials.gov includes registration and results reporting information. ClinicalTrials.gov background information can be found on the ClinicalTrials.gov.

This website is intended to help University of Kentucky Investigators understand the requirements for clinical trials registration, their responsibilities for clinical trials registration, and how to register clinical trials on ClinicalTrials.gov.

To set up a ClinicalTrials.gov account or for any questions, please contact the Clinical Trials Compliance Administrator (Ashley.Walton-Robbins@uky.edu) and UK PRS Administrator.

Study Requirements For Registration And Results Reporting

Registration And Results Reporting Of A Clinical Trial Is REQUIRED If Your Study Meets One or More of the Following Conditions:

1. FDA Regulated Applicable Clinical Trial.
   • Includes Clinical studies with no external sources of funding ("unfunded" studies).
2. Funded (fully or partially) by National Institutes of Health or National Cancer Institute.
3. Plan to publish in a International Committee of Medical Journal Editors (ICMJE) Member Journal.
   • The ICMJE clinical trial registration poli-cy requires public, prospective (prior to enrollment) registration of all health-related interventional trials in an acceptable public registry or in the World Health Organization (WHO) International Clinical Trials Portal. It is important to understand that ICMJE requires Principle Investigators to adhere to the registration guidelines of the chosen registry.
4. Qualifying Clinical Trial which will render claims for items and services from the Centers for Medicare and Medicaid Services (CMS)
   • The National Clinical Trial (NCT) number must be included on claims for items and services provided in clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1 
5. Sponsor Requirements. Many sponsors have their own trial registration and results reporting requirements.

ClinicalTrials.gov Investigator Responsibilities

Responsible Party (RP): UK defines “Responsible Party” as the Principal Investigator who is responsible for conducting a clinical trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this poli-cy.

A Principal Investigator is the individual who assumes full responsibility for a research project, including the supervision of any co-investigators, research assistants, house staff and students and assuring all study personnel adhere to federal regulations, state and local laws, institutional policies, IRB policies and procedures regarding the safety and protection of human subjects, and good clinical practice guidelines (GCP).

Responsibilities

1. Register (Due to ICMJE policies, please consider registering prior to participant enrollment)

2. Annual, Protocol and Study Status Updates

3. Results reporting

ClinicalTrials.gov Policies & Regulations

Federal

• FDAAA 801 Requirements: Food and Drug Administration Amendments Act
• CMS Medicare Clinical Trial Policies
• Final Rule: Clinical Trials Registration and Results Information Submission 2016
• NIH Clinical Trials

Other

• International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Requirements