ClinicalTrials.gov

ClinicalTrials.gov (CT.gov) is a public registry of clinical trials maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). This web-based resource provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. Information on CT.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the website (registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This website and database of clinical studies is commonly referred to as a "registry and results database”

Registration and maintenance of the registration with submission of annual reports, and posting of study updates and results is required for clinical trials meeting the regulatory definition of an Applicable Clinical Trial (FDAAA 801), as well as for clinical trials funded by the National Institutes of Health for a variety of reasons, including:

• Commitment to research participants
• Scientific validity and transparency
• Ethical standards
• Responsible stewardship of federal funds
• Required by law (FDAAA)
• Required for journal publication (ICMJE)
• Required by NCI, for CMS, by WHO, and several foundations
   

Resources

• CT.gov Frequently Asked Questions
• Submission to ClinicalTrials.gov

It is expected that faculty serving as the PI/Responsible Party in CT.gov will register and maintain registrations in a manner compliant with both federal regulations and College policy. The Responsible Party is defined as –

  or

• The Sponsor of the clinical trial (Industry Sponsor, Federal Sponsor, or Investigator-initiated);
• The Principal investigator (PI) of a clinical trial if an Investigator-initiated study or if designated by a sponsor, grantee, contractor, or awardee, so long as 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 FDAAA's requirements for the submission of clinical trial information.

NOTE: Section 801 of the FDA Amendments Act of 2007 (FDAAA 801) amended the Federal Food, Drug, and Cosmetic (FD&C) Act to authorize civil monetary penalties against responsible parties who fail to comply with registration and/or results submission requirements. In addition, in relation to federally funded studies, section 402(j)(5)(A) of the Public Health Service (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. View Legal Consequences.

The International Committee of Medical Journal Editors (ICMJE) clinical trial registration policy requires prospective registration of all interventional clinical studies in a public registry such as ClinicalTrials.gov. Registration is a condition of consideration for publication in ICMJE member journals. View more details of CT.gov Responsible Party.

OCR can assist in determining if registration with ClinicalTrials.gov is necessary.

Office of Clinical Research provides the following ClinicalTrials.gov services across the College:

• Manage setup of new investigator accounts
• Review of new study registrations – consultation with OCR to determine CT.gov study registration and reporting requirements
• Monitor timely reporting of updates, annual reports, and study results
• Study registrations that have been determined to be delinquent with any aspect of registration, or results reporting will be forwarded to Research Compliance Services (RCS) for an assessment of non-compliance with applicable regulations and College policy.

• Outcome Measures Template
• Outcome Measures Example

For specific questions about your study/record or results entry or understanding QA comments, you can email ClinicalTrials.gov directly and/or request a teleconference at register@clinicaltrials.gov

For general assistance with your CT.gov account setup, registration or maintenance, the OCR Office is here to help you at ocr_regulatory@bcm.edu