According to FDA Regulations, all investigators/sponsors are required to register applicable clinical trials on the national public registry, ClinicalTrials.gov, an electronically searchable website that is accessible to the public and maintained by the National Library of Medicine.
Below are simple answers to some of the basic questions regarding the Protocol Registration System (PRS) for ClinicalTrials.gov. For more complete explanations, please use the links below:
It fulfills a commitment to research participants to share results
Compliance promotes scientific integrity and ethical standards
It is required by law (FDAAA) and the World Health Organization (WHO)
It is a requirement for publication by in International Committee of Medical Journal Editors (ICMJE)
Applicable Clinical Trials (ACT) generally include interventional studies involving FDA regulated drugs, biologics or devices in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. These usually exclude phase I trials and small feasibility studies. ACT Check List.
In addition to the FDA qualifications, the ICMJE also requires registration of phase I trials and behavioral interventional studies.
The trial's sponsor is designated the Responsible Party and is responsible for registering the applicable clinical trial. When a pharmaceutical company or a device manufacturer initiates a study, they are usually considered the Responsible Party. When a trial is initiated by a PI, then the PI becomes the Responsible Party and must assure registration of the study.
Studies should be registered before the first patient is enrolled in the study, but there is a 21 day grace period.
Results should be posted no later than 12 months after the completion date. (Results posting examples/tips)
The FDA penalties for responsible parties who fail to register applicable clinical trials may include civil monetary penalties (up to $10,000 per day) and, for federally-funded trials, the withholding or recovery of grant funds.
The ICMJE will not publish manuscripts that do not comply with the registration requirements.
At Lurie Children's we are committed to working with investigators to ensure compliance with the regulations concerning the registration of clinical trials. Our ClinicalTrials.gov site administrator can assist with: