Advocate Center for Pediatric Research
Offices at Oak Lawn and Park Ridge campuses
1775 Dempster St.- 2 South ▪ Park Ridge, IL ▪ 60068
Phone: 847-723-7570 Fax: 847-723-2325
www.advocatehealth.com/pedsresearch
ClinicalTrials.gov Registration Information
for Pediatric Investigators
What is ClinicalTrials.gov?
ClinicalTrials.gov is a registry of federally and privately supported research studies conducted in the United
States and around the world. It is a free service of the U.S. National Institutes of Health (NIH), developed by
the National Library of Medicine, to allow for continual transparency of a clinical trial from the time the study
opens until results are reported. It includes protocol information before and during the trial, as well as results
and adverse event information from the completed trial. The Food and Drug Administration Amendments Act
of 2007 (FDAAA) and the International Committee of Medical Journal Editors (ICMJE) both require the
registration of clinical trials. As of September 27, 2007, all FDA-regulated trials must be registered. Failure to
do so can include civil monetary penalties and an inability to publish your research in the many journals that
adhere to the ICMJE guidelines.
Which trials should be registered? (“Applicable Clinical Trials”)
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The ICMJE defines a clinical trial as “any research study that prospectively assigns human subjects to one
or more health-related interventions, which can include drugs or devices, nutritional therapies, surgical or
radiological procedures, behavioral treatments, or changes in clinical care.”
The FDA requirement relates to:
o Trials of Drugs and Biologics: Controlled clinical investigations (other than Phase 1 investigations) of a
product subject to FDA regulation
o Trials of Devices: Controlled trials with health outcomes of devices subject to FDA regulation (other
than small feasibility studies) and pediatric post-market surveillance
Who is Responsible for Trial Registration? (“Responsible Party”)
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The sponsor of the clinical trial (this is the case in industry-sponsored trials), or
The principal investigator (PI) of the clinical trial, so long as the PI is responsible for conducting the trial,
has access to and control over the data, and has the right to publish the data.
When do I need to register my trial?
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FDA / FDAAA: requires registration within 21 days of enrolling the first study subject
ICMJE: requires registration before the first subject is enrolled as a condition for publication
How are trials registered?
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Clinical trials are registered via a web-based data entry system called the Protocol Registration System
(PRS). Users must have an established user name in order to begin the registration process.
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How do I proceed with registering my study?
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You will need to have a study ID (SID) number to use as your Unique Protocol Number in the
ClinicalTrials.gov registration site. For pediatric studies within Advocate, contact Sandy Maki, at
[email protected], to obtain the SID number.
Follow the instructions as stated in the Standard Operating Procedure (SOP) for Study Registration
If you have determined that you are the “responsible party” for registering the study, as the SOP indicates,
please contact Tom Summerfelt, PhD, VP Research, AHC PRS Administrator, at
[email protected] and include the full name of the PI with his/her phone number
and email address.
 The AHC PRS Administrator will create a user log in name (first initial last name) for the PI.
 The PI will receive an email confirmation from clinicaltrials.gov including a temporary password.
Once you have been provided with a user name, you will be able to log-on to the system
 Log on at: https://register.clinicaltrials.gov/ (AHC Organization name is: AdvocateHC)
 Once logged in, go to the Main Menu page and view the “Quick Start Guide” and the “User’s Guide” to
assist you with the registration.
 You can change your password under the “User Account”
To register, you will use your user name in the PRS system and click on “Create” from the Main Menu
page to begin the registration process and complete the Protocol Data Elements Table.
After you enter your information, a PRS administrator will review your information before it is released
on the Clinicaltrials.gov site.
You can update your information (and later add results) once your trial is released and assigned a NCT
number.
Please contact the Advocate Center for Pediatric Research at [email protected] or
847-723-7570 for any questions.
Are there any additional requirements?
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Yes, if it is an FDA-regulated clinical trial, the law requires the informed consent (or parent permission)
document to state the following text verbatim: “A description of this clinical trial will be available on
http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can
identify you. At most, the Web site will include a summary of the results. You can search this Web site at
any time.”
If you are registering an investigator-initiated trial that is not regulated by FDA, you should modify the
above text for the informed consent document and take out “as required by U.S. law”.
Additional Resources
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Information on Registering and Reporting Results of Clinical Trials: http://prsinfo.ClinicalTrials.gov
ClinicalTrials.gov Web Site: http://www.ClinicalTrials.gov
The International Committee of Medical Journal Editors (ICMJE): http://www.icmje.org
FDAAA Certification to Accompany Drug, Biological Product, and Device Applications or Submissions: See
http://www.fda.gov and search on keywords “FDAAA certification”
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