CLINICALTRIALS.GOV
Registration and Reporting of Clinical Trial Results
ClinicalTrials.gov is a publicly available registry and results database of federally and privately
supported clinical trials conducted in the United States and around the world. The
purpose of ClinicalTrials.gov is to disclose to the public key information about clinical trials that are currently
available, or were previously conducted. ClinicalTrials.gov captures summary protocol information before and during the trial, as well as summary
results and adverse event information of a completed trial. Federal laws, regulations
and editors of prominent medical journals require registration of a clinical trial,
as described below.
Do you need to comply with this requirement?
An LSUHSC-NO investigator who conducts a clinical trial must comply with these requirements if:
- She or he is the Principal Investigator (PI), AND
- The study is investigator-initiated (the clinical trial is not an industry trial in
which the protocol is developed, owned, and sponsored by a company. Industry sponsors
are responsible for registering their trials.)
What kind of studies need to be posted on ClinicalTrials.gov and when?
See the table below for a summary of ClinicalTrials.gov registration requirements:
| Required By: | Types of Studies: | When to Register By: |
| Food and Drug Administration (FDA) | Registration is required for studies that meet the definition of an “applicable clinical trial” (ACT) and either were initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007. | Must register no later than 21 days after enrollment of the first participant |
| National Institutes of Health (NIH) | Regardless of study phase or type of intervention, all NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the “NIH Policy on Dissemination of NIH-Funded Clinical Trial Information” for competing applications and contract proposals submitted on or after January 18, 2017. | Must register no later than 21 days after enrollment of the first participant |
| International Committee of Medical Journal Editors (ICMJE) | For studies that plan to publish within medical journals, ICMJE requires registration of clinical trials. | Must register at or before the time of first participant enrollment |
All investigator-initiated clinical trials must register on ClinicalTrials.gov to comply with federal FDA requirements outlined in FDA 42 CFR 11 (Final Rule) and/or other federal agencies and department's policy or requirements. Studies that fall under multiple registration requirements only need to be registered once. The information posted on ClinicalTrials.gov must be updated throughout the course of the trial, verified at least every 12 months, and the results must be provided when the study ends.
Important note: Even if your investigator-initiated clinical trial does not meet the NIH or FDA clinical trials registration requirements, you are strongly advised to read and consider registering your trial to comply with the following additional requirements:
- International Committee of Medical Journal Editors (ICMJE) for publications purpose
- Center for Medicare & Medicaid for research billing claims for qualifying clinical trial
- Research funders now requiring registration and results reporting
What else should you consider?
- The lead PI for multi-site clinical trials is the individual responsible for complying with the requirements. If the LSUNO investigator is the PI solely for the LSUNO site and is not the primary awardee or lead study PI, then the LSUNO PI is not responsible for posting to ClinicalTrials.gov.
- The holder of any IND, IDE, or HDE from the FDA must ensure compliance with the requirements.
- The primary awardee for NIH-funded trials must ensure compliance with the requirements.
Who can help you with registration and other questions?
- Registration instructions for LSUNO investigators is available here
- Questions should be directed to CTO@lsuhsc.edu.