Clinical Research

Updated November 18, 2014

Requirements for registering clinical trials into ClinicalTrials.gov (the Food and Drug Administration Act (FDAAA) of 2007)

Table of Contents

Introduction
Background
How to Register
Updating Trial Information
Results Reporting


Introduction

ClinicalTrials.gov is a consumer-friendly database with information on clinical studies funded and/or sponsored by the National Institutes of Health (NIH), other federal agencies, and private industry. The database was developed by NIH, through its National Library of Medicine (NLM) in collaboration with the Food and Drug Administration (FDA).

Background

Under the 1997 FDA Modernization Act, NIH was instructed to establish a database of therapeutic clinical trials that is understandable and accessible to the public. The purpose of this legislation was to make information about clinical trials available to members of the public who are suffering from diseases so they can apply to be research subjects.

ClinicalTrials.gov offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

The Food and Drug Administration Amendments Act of 2007 (also called FDAAA) was passed on September 27, 2007. The law now requires that the "Responsible Party" must register and report results for certain clinical trials of drugs, biologics, and devices that are subject to FDA regulation (see Public Law 110-85, Title VIII). It also mandates that some previously optional data elements are now required. In general, the Responsible Party is defined as the sponsor of an applicable clinical trial. The law also allows the role of Responsible Party to be assigned to the Principal Investigator (PI) if the PI 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 FDAAAs requirements for the submission of clinical trial information. For investigator-initiated clinical trials, NIH is generally not the sponsor and, as such, NIH would not be the Responsible Party. Under this law, the Responsible Party is accountable for compliance, including accuracy and completeness of the data. Penalties for failure to register a trial with complete information may include civil monetary penalties and the withholding of federal grant funds.

Clinicaltrials.gov also helps to register trials in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.

How to Register

Clinical studies are registered on clinicaltrials.gov via a web-based data entry system called the Protocol Registration System (PRS) to register clinical studies and submit results information for registered studies. The first step to registering your trial on ClinicalTrials.gov is to secure a PRS account. ClinicalTrials.gov establishes one PRS account for an organization (such as a company, university, or medical center). All investigators from that organization who are conducting studies are typically designated as users of this single PRS account. The organization should designate one or more PRS Administrators to manage the account and to create logins for additional users. If an administrator is not designated, ClinicalTrials.gov may assist in identifying appropriate individuals to act as PRS Administrators for an organization. All PRS accounts should have at least one administrator.

If you know the name and contact information of your organization's Clinicaltrials.gov account administrator, you should contact him/her directly to register your trial. If not, contact register@clinicaltrials.gov for assistance. Further information on how to apply for an account can be found at http://clinicaltrials.gov/ct2/manage-recs/how-apply.

 

Updating Trial Information

Under Public Law 110-85, also called FDAAA, the PI, Responsible Party, and/or the account designee is responsible for maintaining the accuracy of the trial information in ClinicalTrials.gov and for reporting results. The complete and accurate ClinicalTrials.gov record will fulfill both the International Committee of Medical Journal Editors and Federal registration and results reporting requirements, including those mandated under Public Law 110-85.

To update your trial information, logon to Clinicaltrials.gov. Choose MODIFY, then choose EDIT next to your trial's listing. Next choose EDIT next to the block of information you wish to edit. When your editing is complete, choose OK at the bottom of the page. Next choose RESET TO COMPLETED near the top of the page, then APPROVE, and finally RELEASE.

Clinicaltrials.gov Assistance register@clinicaltrials.gov
Clinicaltrials.gov Logon https://register.clinicaltrials.gov
International Committee of Medical Journal Editors requirement http://clinicaltrials.gov/ct2/manage-recs/resources#InternationalCommittee
FDAAA (Public Law 110-85) information http://clinicaltrials.gov/ct2/manage-recs/fdaaa
Clinicaltrials.gov FAQs http://grants.nih.gov/ClinicalTrials_fdaaa/faq.htm

 

Results Reporting

In September 2007, US law Public Law 110-85, Title VIII, also called FDAAA, was enacted to expand the types of clinical trials that must be registered in Clinicaltrials.gov, increase the number of data elements that must be submitted, as well as require submission of results data. Penalties for not complying with the law are significant and may include civil monetary penalties and the withholding of federal grant funds. It is important to note that results-reporting requires a fairly sophisticated knowledge of the study.

To begin entering results for your registered trial logon to Clinicaltrials.gov. Next choose MODIFY, then choose EDIT next to the study listing. Scroll down to "For Completed Studies," then choose ENTER RESULTS. Begin entering results.

Clinicaltrials.gov Assistance register@clinicaltrials.gov
Clinicaltrials.gov Logon https://register.clinicaltrials.gov
FDAAA (Public Law 110-85) information http://clinicaltrials.gov/ct2/manage-recs/fdaaa

 

What NIH Grantees Need to Know About FDAAA

Further information on NIH requirements and developing information concerning FDAAA can be found at http://grants.nih.gov/ClinicalTrials_fdaaa/index.htm.