Required Registration to ClinicalTrials.gov

Table of Contents:

• Introduction
• How To Register
• Updating Trial Information
• Results Reporting
• Background

Introduction

ClinicalTrials.gov is a consumer-friendly database with information on more than 13,500 clinical studies 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). Studies listed in the database are conducted in all 50 states and in more than 100 countries. Clinicaltrials.gov receives more than 4 million page views per month and hosts approximately 17,000 visitors a day.

On September 27, 2007, a US law (Public Law 110-85, Title VIII) was enacted that expands the types of clinical trials that must be registered in Clinicaltrials.gov, increases the number of data elements that must be submitted, and also requires submission of results data. This law mandates that some previously optional data elements are now required. One of those elements is identifying a Responsible Party for each trial. In general, the law defines the Responsible Party 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 conducting the trial and has sufficient data rights in accord with the law. For grants, NIH is generally not the sponsor and, as such, NIH would not be the Responsible Party. Under the new law the Responsible Party will be held accountable for compliance. Penalties for failure to register a trial with complete information are significant and may include civil monetary penalties and, the withholding of federal grant funds.

NINDS remains committed to assist our investigators on how to comply with the new law, because under the new law the PI and/or Responsible Party now is responsible for the accuracy and completeness of the data.

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). The first step to registering your trial on ClinicalTrials.gov is to secure a PRS account. You can apply for an individual account, you can register your trial through your organization's existing account, or you can apply for an organization account. 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.

To apply for an individual account	http://prsinfo.clinicaltrials.gov/gettingIndivAccount.html
To apply for an organization account	http://prsinfo.clinicaltrials.gov/gettingOrgAccount.html
NIH Guidance on Registration Requirements	http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
Clinicaltrials.gov Data Elements and definitions	http://prsinfo.clinicaltrials.gov/definitions.html

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://prsinfo.clinicaltrials.gov/icmje.html
FDAAA (Public Law 110-85) information	http://prsinfo.clinicaltrials.gov/fdaaa.html
Clinicaltrials.gov FAQs	http://grants.nih.gov/grants/policy/hs/faqs_aps_clinical_trials.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, and also 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://prsinfo.clinicaltrials.gov/fdaaa.html
Basic Results Elements and Definitions	http://prsinfo.clinicaltrials.gov/results_definitions.html

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. The database (and its companion public web site) was created and is maintained by NLM. See www.clinicaltrials.gov.

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.