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Clinical Trials Registration

On September 27, 2007 Congress enacted U.S. Public Law 110-85 (also known as H.R. 3580, or Food and Drug Administration Amendments Act of 2007).  This act mandates the expansion of ClinicalTrials.gov, expands the required submission elements and establishes penalties for not listing a trial.   The FDA requirements are in addition to the 2005 policy established by the International Committee of Medical Journal Editors (ICMJE) requiring the entry of clinical trials in a public registry prior to subject enrollment as a condition of consideration for publication of the trial results.   All applicable clinical trials must be registered as required by FDA regulation. 

The FDA regulations require the responsible party to register applicable clinical trials.  The responsible party is the sponsor of the clinical trial, meaning the person who initiates a clinical investigation.

  • For investigator-initiated trials, the lead principal investigator responsible for initiating, conducting and coordinating the overall clinical trial is responsible for registration
  • For sponsor-initiated trials the sponsor is responsibility for registration
  • For trials sponsored or funded wholly or in part by the NIH the Principal Investigator is responsible for registration
  • For trials associated with Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications with the FDA the IND/IDE holder is responsible for registration
  • The sponsor, grantee, contractor, or awardee may designate the principal investigator of a clinical trial as the responsible party, provided that the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for submitting information under the law

If unclear who is responsible registering an applicable clinical trial, investigators should consult with the sponsor, funding agency, and/or other study investigators to define who the responsible party will be.   

You are responsible ensuring that the information is complete, accurate and updated.  This includes reviewing the listing and making necessary changes every 6 months or more frequently if significant changes occur.  You are also responsible for noting when enrollment ceases.   

  • Search ClinicalTrials.gov to ensure that the trial is not already listed. NIH-sponsored clinical trials and many industry-sponsored trials have already been registered on this site. If the trial is not listed, continue
  • Establish an account with the ClinicalTrials.gov Protocol Registration System (PRS) by sending an e-mail message to TJU ’s PRS administrator, Roseann.Talarico@jefferson.edu. The subject line should state “ClinicalTrials.gov Protocol Registration” and the body of the message should contain your name, telephone number, and email address
  • Within 2 business days, you will receive an e-mail message from ClinicalTrials.gov containing your login name and temporary password
  • Once you have received your login information, register the trial. This process will take approximately 1 hour, and it will be helpful to have the protocol, informed consent document, and IRB approval (if available) on hand.  IRB approval is not required to register a trial.  Note that this system offers the option to save data if you do not have time to complete the entire process
  • To begin the registration process, go to the ClinicalTrials.gov registration website [https://register.clinicaltrials.gov/]. Complete the login fields. In the “Organization” field, enter ThomasJeffersonU
  • The “Main Menu” page will appear. The “User Account” link provides information on changing your temporary password, and this should be done as soon as possible. This link also has a helpful “User’s Guide”
  • To complete the protocol template, begin from the “Main Menu” page, go to “Protocol Record” and select “Create.” You can copy and paste information from the protocol into the data fields.  A list of all the variables you will be asked to provide can be found at http://prsinfo.clinicaltrials.gov/definitions.html  and a guided tour is available at http://prsinfo.clinicaltrials.gov/title.html

Some suggestions for completing certain items that you might not have available are:

  • Unique protocol ID: The Thomas Jefferson University IRB number is recommended
  • Secondary IDs: The grant number, funding agency number or other funding source number is recommended
  • Board Name (Full name of the approving human subjects review board):
    Thomas Jefferson University Institutional Review Board
     
  • Board Contact (Contact information for the human subjects review board):
    Name: Kyle Conner Phone: (215) 503-8966 eMail: kyle.conner@jefferson.edu
  • Oversight Authorities : should always include United States: Institutional Review Board; other oversight authorities such as the FDA may also apply depending on the clinical trial

When the template is complete, hit “Submit.” The template will be forwarded to the University’s PRS administrator who will review it and release the approved content to ClinicalTrials.gov   Information should be reviewed and updated as needed every 6 months or more frequently if changes occur.  

Registration is required for any research study that:

  • Prospectively assigns human subjects to intervention and at least one concurrent control or comparison groups AND
  • Uses a drug, biologic, or device as the intervention or control/comparison AND
  • Studies the safety, efficacy or cause-and-effect relationship between an intervention and a health outcome

The registration requirement does not apply to:

  • The use of FDA approved, marketed products used in the course of medical practice
  • Phase I clinical investigations of drugs or biologics
  • Small clinical trials to determine the feasibility of a device or clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes
  • FDA required pediatric post-marketing surveillance of devices
  • Purely observational studies, meaning those studies where the assignment of the intervention is not at the discretion of the investigator

Investigators and sponsors are encouraged to register all clinical trials to ensure they meet the publication requirements of the International Committee of Medical Journal Editors (ICMJE) and to promote transparency in clinical research.   

To promote transparency of the clinical trial process, the International Committee of Medical Journal Editors (ICMJE) established a policy in 2005 requiring the entry of clinical trials in a public registry prior to subject enrollment as a condition of consideration for publication of the trial results.  The ICMJE requires any research project that prospectively assigns human subjects to intervention and at least one concurrent control or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome should be registered. Studies designed for other purposes such as evaluation of pharmacokinetics or toxicity (e.g. phase I trials) are not required to be registered.  Medical intervention is defined broadly and includes any intervention used to modify a health outcome, including drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.

On September 27, 2007 Congress enacted U.S. Public Law 110-85 (also known as H.R. 3580, or Food and Drug Administration Amendments Act of 2007).  This act mandates the expansion of ClinicalTrials.gov, expands the required submission elements and establishes penalties for not listing a trial.  Investigators and sponsors must ensure that applicable drug, biologic and device trials are registered within 21 days of enrollment of the first subject and preferable before first subject enrollment.  The legislation also requires applications or progress reports for any clinical trials required to be registered which are funded in whole or in part by a grant from any agency of the Department of Health and Human Services  to contain specific information certification registration in ClinicalTrials.gov.    

How do the FDA registration requirements affect NIH funded studies?   Competing renewal applications that include studies that are required to be registered must include as part of the Human Subjects Section of the Research Plan the following items: 

  • A statement that “This application includes a trial which requires registration in ClinicalTrials.gov,”
  • The National Clinical Trial (NCT) number (i.e. the ClinicalTrials.gov number)
  • Brief Title as listed in ClinicalTrials.gov, and
  • The name of the individual or entity responsible for registering the study (responsible party) for each study being conducted under the application. (As grantee, Thomas Jefferson University designates the lead investigator of the trial as the responsible party.)

If the application does not include studies that are required to be registered the Human Subjects Section of the Research Plan should include a statement that “This application does not include a trial which requires registration in ClinicalTrials.gov.”  These requirements apply to all competing applications submitted to the NIH on or after January 25, 2008.

New applications that include studies that are required to be registered must include as part of the Human Subjects Section of the Research Plan a statement that “This application includes a trial which requires registration in ClinicalTrials.gov.”  The study would then need to be registered and the National Clinical Trial (NCT) number, Brief Title as listed in ClinicalTrials.gov and the individual or entity responsible for registering the study (responsible party) for each study being conducted under the application as part of the Just-In-Time (JIT) information.  If a New application does not include studies that are required to be registered the Human Subjects Section of the Research Plan should include a statement that “This application does not include a trial which requires registration in ClinicalTrials.gov.”  

Non-competing progress reports that include studies that are required to be registered must include as part of the Human Subjects Section of the Progress Report the following items:  

  • A statement that “This application includes a trial which requires registration in ClinicalTrials.gov”
  • The National Clinical Trial (NCT) number (i.e. the ClinicalTrials.gov number)
  • Brief Title as listed in ClinicalTrials.gov and
  • the name of the individual or entity responsible for registering the study (responsible party) for each study being conducted under the application.  (As grantee, Thomas Jefferson University designates the lead investigator of the trial as the responsible party.)

If the application does not include studies that are required to be registered the Human Subjects Section of the Research Plan should include a statement that “This application does not include a trial which requires registration in ClinicalTrials.gov.”   These requirements apply to all non-competing progress reports with budget start dates of April 1, 2008 or later (applications due on or after 2/1/08).

Studies conducted under an IND or IDE must include in the informed consent documents and the informed consent process a statement that clinical trial information for the study has been or will be submitted for inclusion in ClinicalTrials.gov as required by FDA regulations.

A certification must accompany human drug, biological, and device product submissions made to FDA. At the time of submission of an IND, IDE or BLA application or submission of a report, amendment, supplement or resubmission, such application or submission must be accompanied by a certification that all applicable requirements related to clinical trial registration have been met. Where available, such certification must include the appropriate National Clinical Trial (NCT) numbers.

The official certification form, Form FDA 3674 entitled "Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank, is available on FDA's Web site.

For sponsor held INDs, IDEs and BLAs the sponsor must provide the certification.  For investigator held INDs, IDEs and BLAs the individual holding the IND, IDE or BLA must provide the certification.

The NIH has a posted information on clinical trials registration at: http://grants.nih.gov/grants/policy/hs/faqs_aps_clinical_trials.htm  

Contact Roseann Talarico by email (roseann.talarico@jefferson.edu) or phone (215-503-4743) to establish a user account to register a study with the ClinicalTrials.gov Protocol Registration System 

ClinicalTrials.gov: www.clinicaltrials.gov

International Committee of Medical Journal Editors: http://www.icmje.org/clin_trialup.htm  

Center for Drug Evaluation and Research; US Food and Drug Administration.  Guidance for industry information program on clinical trials for serious or life-threatening diseases and conditions. Available at: http://www.fda.gov/cder/guidance/4856fnl.htm.  

WHO International Clinical Trials Registry Platform (ICTRP): http://www.who.int/ictrp/en/  

National Library of Science and Medicine ClinicalTrials.gov Questions http://www.nlm.nih.gov/services/faqctgov.html#info