ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. In accordance with the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), applicable trials must be registered and have results reported on clinicaltrials.gov. In addition, trial registration is required for journal publication of any clinical trial results.

Applicable trials must be registered on clinicaltrials.gov before participant enrollment begins. Please see our FAQs below for more information on applicable trials. 

Request a ClinicalTrials.gov Account Log in to Clinicaltrials.gov


Register Your Study

Follow our step-by-step study registration guide to register and maintain your study. 

Please email Sarah Ford-Trowell at strowell@mfa.gwu.edu to request a clinicaltrials.gov account. 

If you are unsure if you need to register your study, please refer to our FAQs below or email us at clinicalresearch@mfa.gwu.edu.


Report Your Results 

Ready to report results to ClinicalTrials.gov?

Step one is to gather the data that you've collected for the following:

  1. Participant Flow: How many people started versus finished each period of your study and how many dropped out along the way.
    Most studies only have one period. However, some studies (for example, crossover studies) may have more. For example: Period 1: “First Treatment for 2 Weeks”, Period 2: “Washout, 3 Week”: Period 3: “Second Treatment for 2 Weeks”. 
  2. Baseline Characteristics: Demographics data, such as age/sex/ethnicity/race of your participants, and any study-specific baseline measures that you collected, if any.
  3. Outcome Measure Data: These are very basic tables of the data that you collected for each of your Outcome Measures. The table rows will be the measurement and the columns will be the arms/groups of participants.  
  4. Adverse Events: All SAEs, and any AEs that occurred at a frequency over a certain threshold (if any).

Next, follow the PRS Guided Tutorials for Entering Results, which will take you through the process step-by-step.

If you have questions while working through the tutorials, contact Sarah Ford-Trowell at strowell@mfa.gwu.edu or register@clinicaltrials.gov.


Identifying and Resolving Records with Problems

Problems will be listed in your Record List. When viewing your Record List on your home page, review the Problems column to identify any Problems on your records. Please follow our guide to update your records. 

For more information on the problems records may have, please see the PRS User's Guide


New NIH Policy Requirements

The National Institutes of Health (NIH) will require all research seeking grant funds that result in scientific data to submit a data management and sharing plan (DMSP) starting January 25, 2023. 
Required Documents are:

  • A two-page data management and sharing plan as part of the funding application. This plan will outline how the generated scientific data and accompanying documentation will be managed and shared
  • A data management and sharing plan as part of the grant application process

By submitting a DMSP, it will maximize the appropriate sharing of scientific data generated from NIH-funded or conducted research in the plant, with justified limitations of exceptions.

For more information on the new DMSP policy, please review the NIH Scientific Data Sharing Page: The Who, What, Where and When of the NIH Data Management and Sharing (DMS) Policy.


What is a Data Management Plan (DMP)?

A DMP is a formal, living document, that outlines what you will do with your data during and after your research project. Even if your study is not being funded by a federal agency, like the NIH, it is still best practice to have a DMP in place. 

All of the following must be included in your DMP (provided by the NIH):

  • Data Type - Include the type of data and estimated amount of data being generated. Use general terms and descriptions about data modality (e.g. imaging, genomic, mobile, survey), how the data is aggregated and processed.
  • Related Tools, Software, and Code - Indicate if specialized tools are needed to reproduce your research and how they can be accessed.
  • Standards - An indication of what standards will be applied to the scientific data and associated metadata (i.e., data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation).
  • Data Preservation - The name of the repository, where scientific data and metadata will be archived. For more information see NIH Repositories for Sharing Scientific Data.
  • Access and Timelines - A description of how the data will be made available and what unique persistent identifiers (PID) you will use to support reporting out on your progress and outputs. Provide the timeframe with the expectation that the data should be made available as soon as possible.
  • Access, Distribution, or Reuse Considerations - Including informed consent, privacy and confidentiality protections like de-identification and Certificates of Confidentiality, any data use agreements or licensing limitations.
  • Oversight of Data Management and Sharing - How and when the data management plan will be monitored and managed, and by whom (e.g. , titles, roles).

Frequently Asked Questions

Are there penalties if I don’t register my study and report the results?

Yes, Section 801 of FDAAA amended the FD&C Act authorizes civil monetary penalties against responsible parties who fail to comply with registration and/or results submission requirements.

In relation to federally funded studies, section 402(j)(5)(A) of the PHS Act provides for the withholding of remaining or future grant funds from a grantee for failure to submit clinical trial registration and results information. ICMJE policy requires, and recommends that all medical journal editors require, registration of clinical trials prior to the start of enrollment as a condition of consideration for publication.

Additionally, ICMJE expects authors to ensure that they have met the requirements of their funding and regulatory agencies regarding posting of results to ClinicalTrials.gov.

When should I register my study in ClinicalTrials.gov?

GWU requires studies to be submitted before enrollment begins. Applicable Clinical Trials and NIH-funded clinical trials are required to register within 21 days of enrolling the first subject. However, ICMJE policy requires registration prior to the start of enrollment.

When do I need to report results?

Results must be posted within 12 months of the Primary Completion Date, that is, within 12 months of the last study visit where you collected data for your primary outcome measure. This 12 month deadline has nothing to do with IRB closure, publication, data analysis, etc. so be prepared to enter your data within 12 months of your last study visit.

What are my responsibilities as Record Owner?

The record owner can be the PI or a study coordinator who has been delegated this role. As Record Owner you are responsible for:

  • Keeping the record up to date
    • Update the record at least every 12 months until the study status is changed to “Completed”, “Terminated”, or “Withdrawn” (update at least every 6 months while actively recruiting).
  • Addressing problems, errors, and Major Issue comments in the record in a timely manner
  • Reporting study results, if required, within 12 months of the study Primary Completion Date (usually the last study visit).

Please notify Sarah Ford-Trowell (strowell@mfa.gwu.edu) who you would like to be your designated Record Owner, or if the current Record Owner is leaving the institution and who you want to replace them so an account can be set-up or transferred.

What are my responsibilities as the Responsible Party?

The P.I. or the study Sponsor is responsible for:

  • Registering the study on ClinicalTrials.gov
  • Maintaining, updating, and releasing the record
  • Reporting basic results data to ClinicalTrials.gov, if required

Please note that incoming or departing faculty must transfer their ClinicalTrials.gov records with them.

Do I need to register my study?

The regulations governing posting require that Applicable Clinical Trials be registered, and have basic results reported to ClinicalTrials.gov. See Which Trials Must be Registered.

Some funding agencies, NIH, Bill and Melinda Gates, also require posting as do many journals.

For investigator-initiated studies conducted by GWU MFA faculty, the faculty P.I. is responsible for registering the study and maintaining the posting.

For industry-sponsored trials, the sponsor will register and maintain the record.

How do I get an account in ClinicalTrials.gov?

Please email Sarah Ford-Trowell at strowell@mfa.gwu.edu if you need an account set up for you.

What if I am leaving the institution? 

If you are a responsible party/PI leaving the institution, please follow the our PI Departure Flowchart and refer to the Departure Checklist.