Do you want to participate in a clinical study? See information for patients and families.

Submit Studies allows the registration of clinical studies with human subjects that conform to:

  • Any applicable human subject or ethics review regulations (or equivalent) and
  • Any applicable regulations of the national or regional health authority (or equivalent)

New to registering studies? See For Study Record Managers.

Why Should I Register and Submit Results?

Learn about the purpose of study registration and results submission. Includes an overview of applicable laws and policies.

FDAAA 801 Requirements

Learn about Section 801 of the Food and Drug Administration Amendments Act and the basic requirements for registering clinical trials and submitting summary results, including information about the Responsible Party, Applicable Clinical Trials, deadlines, and penalties.

How to Apply for an Account

Learn how to apply for an account to access the Protocol Registration System (PRS), the Web-based system used for submitting study data to

How to Register Your Study

Review the basic steps for study registration, find out what data elements are required, and learn about the record review process.

How to Edit Your Study Record

Learn about required updates, how to edit study records, and how to view earlier versions of a record.

How to Submit Your Results

Review the basic steps for submitting results, find out what data elements are required, and learn about the record review process.

Frequently Asked Questions

Review frequently asked questions for sponsors or investigators regarding PRS and entering study data.

Support Materials

Find data element definitions and resources related to registration and results submission, as well as links to relevant laws and policies. Includes links to resources on external sites such as the Food and Drug Administration and International Committee of Medical Journal Editors.

Training Materials

View National Library of Medicine presentations and workshop materials for researchers and study record managers on submitting data to and related laws and policies.

This page last reviewed in August 2012