ClinicalTrials.gov Registration

Effective January 18, 2017 All NIH-funded clinical trials are expected to register AND submit results information to Clinicaltrials.gov. (NIH Policy)

How to Request a ClinicalTrials.gov Account
  1. Request an account with the ClinicalTrials.gov Protocol Registration System (PRS) by sending an email to the Syracuse University Office of Research Integrity and Protections Assistant Director, Katie Joa (kjoa01@syr.edu), with “ClinicalTrials.gov Protocol Registration” in the subject line. Please include your name, telephone number, and email address.

  2. You will receive an email reply containing your login name, and a message directly from ClinicalTrials.gov containing your temporary password.

  3. Log on to the Protocol Registration and Results System (PRS) using your login name and temporary password.  The Organization name is SyracuseU.

  4. From the Accounts drop down menu, select "Change Password."  The temporary password provided should be updated to a unique password of your choosing as soon as possible.

How to Register a Study

It takes approximately 1 hour to enter registration information.  The system offers the option to save data as you go in case you do not have time to complete the entire process in one sitting.

  1. Request an account with the ClinicalTrials.gov Protocol Registration and Results System (PRS) account.
    • See above
  2. Learn about submission requirements.
    • 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 the Protocol Registration and Results System (PRS).
    • Organization name is SyracuseU
    • To retrieve forgotten passwords for existing PRS accounts, click on the Forgot password link on the PRS Login Page.
  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.
    • Click the green "Entry Complete" button to submit the registration.
    • See the 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.

 

 

How to Maintain the Record

Records must be reviewed and the Record Verification Date updated at least every 6 months, even if no other updates are required.

Additionally, the following fields must be updated within 30 days of a change:

  • Overall Recruitment Status
  • Primary Completion Date
  • Study Start Date
  • Intervention names (must update to a non-proprietary name within 30 days after a non-proprietary name is established)
  • Expanded Access Status and Expanded Access Type
  • Individual Site Status
  • Human Subjects Protection Review Board Status
  • Study Completion Date
  • Responsible Party and RP Contact Information
  • Changes in the protocol that are communicated to subjects
  1. Login to the Protocol Registration and Results System (PRS).
    • Organization name is SyracuseU
    • To retrieve forgotten passwords for existing PRS accounts, click on the Forgot password link on the PRS Login Page.
  2. Click on "Edit Record" under the Protocol Records heading on the PRS main menu.
    • 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.
  3. Preview, inspect, and release (submit) the record.
    • See the 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.
How to Enter Results

Results are due within ONE YEAR of the primary completion date (the date the final subject was examined or received an intervention)

  1. Learn about the requirements for submitting results.
    • See the Results Data Element Definitions and the Scientific Information sections 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. Users are encouraged to provide all data elements in order to provide a complete description of the study results.
  2. Login to the Protocol Registration and Results System (PRS).
    • Organization name is SyracuseU
    • To retrieve forgotten passwords for existing PRS accounts, click on the Forgot password link on the PRS Login Page.
  3. Update the Protocol Section and release (submit) the record.
    • Ensure that the information in the Protocol Section is up-to-date before starting the Results Section (for example, the Overall Recruitment Status, Study Start Date, Primary and Study Completion Dates, Actual Enrollment, and arm and intervention information).
    • Begin results submission after the updated record has been published on ClinicalTrials.gov.
  4. Enter the required and optional results data elements.
    • For basic help with using Protocol Registration and Results System (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.
    • See the Results Data Element Definitions for descriptions of each required data item.
    • See the results data preparation checklists and simple results templates for each module, listed in the Scientific Information section above, for the data you will need and a view of the data elements in a tabular format.
    • See the Helpful Hints(PDF) for tips on entering results data, including three examples of common study models (parallel design, crossover design, and diagnostic accuracy studies) and measure types.
  5. Preview, inspect, and release (submit) the record.
    • See the gov results 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.

 

Need more help?

Additional training materials including presentations on submitting results data, examples of common errors, and example studies for results data entry can be found on the ClinicalTrials.gov website (Training Materials)