ClinicalTrials.gov Policies and Guidance

Overview

Even if your research is not considered a clinical trial, it is very important that you determine whether your study is required to be listed on ClinicalTrials.gov before you start your study.

A checklist tool is now available on ClinicalTrials.gov to help you determine whether your study is required by law to register and report results. There are many reasons to register a trial on ClinicalTrials.gov, including but not limited to: NIH policy, external billing requirements, and preserving the ability to publish in more than 2,000 journals. Ultimately, the purpose of registering with ClinicalTrials.gov is to improve transparency with the public and to show others the type of research that is being done, in order to prevent duplication of effort.

These resources provide additional guidance and policies related to registration in ClinicalTrials.gov. You can find more information about training on ClinicalTrials.gov in the Education and Training section.


Links

U-M Regulatory Affairs – Clinical Trial Registration Requirements and Decision Trees
The Office of Regulatory Affairs offers an overview of the steps researchers must take to register their clinical trials on ClinicalTrials.gov.

ClinicalTrials.gov – FDAAA 801 Requirements
This page provides summary information on the clinical trial registration and results submission requirements described in Section 801 of the Food and Drug Administration Amendments Act, known as FDAAA 801.

International Committee of Medical Journal Editors (ICMJE) Requirements
Information regarding the obligation to register clinical trials as a condition of consideration for publication from the International Committee of Medical Journal Editors can be found on their website.


Questions and Disclaimer

If you have questions about any of the resources on this page, please contact the sponsoring office directly. MICHR is not responsible for the content of these resources.

Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.

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