How to Register Your Study

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Contents

• Steps for Registering a Clinical Study
• Considerations for Observational Studies and Expanded Access Records
• ClinicalTrials.gov Protocol Information Review Process
• Required Registration Updates

Steps for Registering a Clinical Study

The steps on this page describe the overall process of registering studies. If you would like step-by-step instructions for entering registration information into the PRS, see the PRS Guided Tutorials. The tutorials include a quick overview guide called Entering a New Registration that briefly summarizes how to use the tutorials to support registering a study. [Requires a browser that supports HTML5.]

1. Determine who is responsible for registering the clinical study and which Protocol Registration and Results System (PRS) account should be used.
   • See the Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF) for the complete statutory definition of "responsible party" under Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) and an elaboration of its meaning.
     • More information on identifying the Responsible Party for National Institutes of Health (NIH) grantees is available from the NIH Office of Extramural Research.
   • See How to Apply for a PRS Account to learn how to determine whether your organization already has a PRS account, contact your organization's PRS account administrator, or apply for a PRS account.
2. Learn about submission requirements.
   • ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to:
     • Any applicable human subject or ethics review regulations (or equivalent)
     • Any applicable regulations of the national or regional health authority (or equivalent)
   • See Why Should I Register and Submit Results? for background information on the reasons for registering a clinical study.
   • See the Protocol Registration Data Element Definitions for descriptions and examples of the information to be submitted. Some data elements are required by ClinicalTrials.gov, while others are optional for ClinicalTrials.gov but may be required by the International Committee of Medical Journal Editors, or other organizations. Users are encouraged to submit all data elements in order to provide a complete description of the study.
     
     • See the Interventional Study Protocol Registration Template for a formatted summary of the relevant interventional study data elements for each registration module. The template is intended to help investigators understand and gather the data needed to complete each registration module.
3. Login to PRS.
   • To retrieve forgotten passwords for existing PRS accounts, click on the Forgot password link on the linkToPRSLogin().
   
   
4. Enter the required and optional data elements.
   • For basic help with using PRS, review the Quick Start Guide found in the Help section of the PRS main menu. More detailed instructions are available in the PRS User's Guide, also found on the PRS main menu.
5. Preview, inspect, and release (submit) the record.
   • See the ClinicalTrials.gov Protocol Review Criteria (PDF) for a description of items that should be addressed before releasing the record to ClinicalTrials.gov.
   • Verify in PRS that the Record Status is released. The record will not be processed by ClinicalTrials.gov unless it is released. Only the Responsible Party or a PRS account administrator can release the record.

Considerations for Observational Studies and Expanded Access Records

Registering Observational Studies

The Observational Study Type (see Study Type data element on ClinicalTrials.gov) can be used to register studies of human beings in which biomedical and/or health outcomes are assessed in predefined groups of individuals, but the investigator does not assign specific interventions to the study participants. This will provide access to the Observational Study Design data elements on ClinicalTrials.gov, including Observational Study Model, Time Perspective, and Biospecimen information.

The Patient Registry Observational Study Subtype (see Study Type data element on ClinicalTrials.gov) can be used to indicate that an observational study is also considered to be a Patient Registry. The Agency for Healthcare Research and Quality (AHRQ) defines a Patient Registry as including an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single-purpose or ongoing data collection programs that address one or more questions.

Observational study records should be updated and maintained in the same manner as interventional study records.

Registering Expanded Access Records

Expanded access (sometimes also referred to as "compassionate use") is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. A responsible party for an applicable clinical trial (ACT) of an investigational drug product or biological product who is both the manufacturer of the drug product and the sponsor of the trial is required to submit expanded access information to ClinicalTrials.gov. Note that a physician who submits an individual patient expanded access Investigational New Drug Application (IND), including for emergency use, to the U.S. Food and Drug Administration generally would not be required to submit expanded access information to ClinicalTrials.gov.

For an ACT studying an investigational drug or biological product for which expanded access is available under FDA regulations, the responsible party would select "Yes" for the Availability of Expanded Access data element and submit information for an expanded access record if certain other conditions are met (see Who is required to submit expanded access information to ClinicalTrials.gov and what information is required? FAQ).

If expanded access is available at the time the clinical trial registration information for an ACT of an investigational drug product or biological product is submitted, then registration information for the expanded access record must also be submitted. If expanded access becomes available after the registration information for an ACT is submitted, then the Availability of Expanded Access data element for the ACT must be updated and the expanded access record must be submitted not later than 30 calendar days after expanded access to the investigational drug or biological product becomes available.

Additional information about expanded access is available on the Food and Drug Administration (FDA) and NIH websites:

• FDA: Expanded Access (Compassionate Use)
• FDA: For Patients - Learn About Expanded Access and Other Treatment Options
• FDA: Expanded Access for Medical Devices
• ClinicalTrials.gov FAQ: What is expanded access?
• ClinicalTrials.gov FAQ: Who is required to submit expanded access information to ClinicalTrials.gov and what information is required?
• ClinicalTrials.gov FAQ: When is expanded access information required to be submitted to ClinicalTrials.gov?
• ClinicalTrials.gov: Registration Data Element Definitions for Expanded Access

ClinicalTrials.gov Protocol Information Review Process

A ClinicalTrials.gov staff member will review the study record after it is released (submitted) and before it is published on ClinicalTrials.gov. This review will focus on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting. You may be asked to clarify items or make corrections to the record before publication. Please note that the review process may take up to a few days. Ensuring that the record is consistent with the ClinicalTrials.gov Protocol Review Criteria (PDF) before releasing it will expedite publication on the site.

After you release a record and it is accepted by review staff for publication, the record, including its NCT Number, will be available on ClinicalTrials.gov within 2–5 business days.

Required Registration Updates

Responsible Parties should update their records within 30 days of a change to any of the following:

• Individual Site Status and Overall Recruitment Status data elements on ClinicalTrials.gov
• Primary Completion Date data element on ClinicalTrials.gov on ClinicalTrials.gov.

As described in 42 CFR Part 11, additional information must also be updated within 15 or 30 days of a change. Other changes or updates to the record must be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.

See How to Edit Your Study Record for details on updating study information.

Submitting Results

For certain clinical trials subject to FDAAA 801 and 42 CFR Part 11, the Responsible Party should submit summary results no later than 12 months after the Primary Completion Date, defined as the date the final participant was examined or received an intervention for purposes of final collection of data for the primary outcome (see Primary Completion Date data element on ClinicalTrials.gov). See How to Submit Your Results and FDAAA 801 and the Final Rule for more information.