How to Register Your Study

Contents

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

Steps for Registering a Clinical Study

1. Determine who is responsible for registering the clinical study and which Protocol Registration 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.
     • Additional 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 an Account to find out whether your organization already has a PRS account, learn how to contact your organization's PRS account administrator, or apply for a PRS account.
   • ClinicalTrials.gov staff developed the following online presentation to help sponsors or investigators with study registration. Adobe PDF handouts and a transcript of the presentation are also provided.
     
     Protocol Registration System (PRS) Accounts and Registration (6:33)
     Annice M. Bergeris, Information Research Specialist, ClinicalTrials.gov, NLM
     Discusses how to apply for a PRS account, enter trial registration data, and modify a record. Provides an overview of protocol review criteria.
     
     
2. Learn about submission requirements.
   • ClinicalTrials.gov 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)
   • See Why Should I Register and Submit Results? for background information on the reasons for registering a clinical study.
   • See the Protocol 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 FDAAA 801, 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.
     
     
3. Login to the PRS. To retrieve forgotten passwords for existing PRS accounts, click on the Forgot password link on the Protocol Registration System (PRS).
   
   
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 in the PRS main menu.
   • ClinicalTrials.gov staff developed the following online presentation to help sponsors or investigators with study registration. Adobe PDF handouts and a transcript of the presentation are also provided.
     
     Protocol Registration System (PRS) Information and Data Review Process (15:58)
     Tony Tse, Ph.D., Program Analyst, ClinicalTrials.gov, NLM
     Provides an overview of data entry using the PRS and of the data review process conducted by ClinicalTrials.gov staff.
     
     
5. Preview, inspect, and release (submit) the record
   • See the ClinicalTrials.gov Protocol Review Criteria (PDF) document for a description of items that should be addressed before releasing the record to ClinicalTrials.gov.
   • Verify in the 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 Programs

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 Sub-Type (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, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single purpose or on-going data collection programs that address one or more questions. Additional information about patient registries is available at AHRQ's Registry of Patient Registries.

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

Registering Expanded Access Programs

Expanded access records describe the procedure for obtaining an experimental drug or device outside of a clinical trial. To register information about an expanded access program, choose "Expanded Access" for the Study Type (see Study Type data element on ClinicalTrials.gov).

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

When registering a clinical trial that includes a drug or device that is also available via an expanded access program, "Has Expanded Access?" should be answered "Yes" (see Expanded Access and Has Expanded Access? on ClinicalTrials.gov). Also provide the ClinicalTrials.gov Identifier (NCT Number) for the expanded access record.

Additional information about expanded access is available on the NLM and Food and Drug Administration Web sites:

• What Is Expanded Access?
• Access to Investigational Drugs Outside of a Clinical Trial (Expanded Access)
• IDE Early/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) document before release 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:

• Recruitment Status and Overall Recruitment Status
• Completion Date (Primary Completion Date data element in ClinicalTrials.gov)

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 trials subject to FDAAA 801, Responsible Parties should submit summary results no later than 12 months after the date of final data collection for the prespecified primary outcome measure (Primary Completion Date data element in ClinicalTrials.gov). See How to Submit Your Results and FDAAA 801 Requirements.