ClinicalTrials.gov is a clinical trial database that was established by the National Institute of Health (NIH) as a central resource to provide current information on clinical trials to members of the public and health care providers. It is run by the National Library of Medicine (NLM) at the NIH and is the largest clinical trials database with privately and publicly funded clinical studies conducted around the world.
Clinical trial registration is managed in the Protocol Registration and Results System (PRS), which is a web-based data entry system to enter and update clinical trial information. The Clinical Trials Office (CTO) currently serves as the PRS administrators for Columbia University (CU). The CU PRS administrators provide assistance to CU staff on creating and managing PRS accounts, as well as performing preliminary quality assurance reviews of the records. To create a new PRS account, or for assistance with a preexisting account, please contact the CU PRS administrators at [email protected].
For assistance with trial registration or results submission on www.clinicaltrials.gov, please contact the CU PRS administrators at [email protected].
What is required?
In general, there are 3 groups of studies that must be registered on ClinicalTrials.gov:
1. Applicable Clinical Trials (ACTs) per FDAAA/Final Rule:
- Phase 2, 3 and 4 interventional studies;
- Studies involving drugs, biological products and medical devices regulated by the FDA; and
- Studies having at least one site in the United States or one of its territories or are conducted under an IND or IDE.
Excluded studies include Phase 1 drug trials, small feasibility/pilot studies of devices, behavioral interventions and non-interventional (observational) clinical research.
If you need assistance in determining whether your study meets the definition of an ACT, click here.
2. NIH-funded Clinical Trials: The 2016 NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information applies to all trials funded in whole or in part by the NIH, including Phase 1 trials of drug and biological products, small feasibility studies of device products and clinical trials of behavioral, surgical and other types of health and medical interventions. Trials that are subject to the 2016 NIH Policy must be registered and updated on www.clinicaltrials.gov in accordance with the requirements set forth by the 2016 HHS Final Rule.
NOTE: This policy only applies to clinical trials that were awarded on or after January 18, 2017 and initiated on or after January 18, 2017. NIH proposals that meet the definition of a "clinical trial" by the NIH and require registration will note the registration requirement in the Notice of Award (NOA).
3. Clinical trials being considered for publication: Registration is required by all journals that follow the International Committee of Medical Journal Editors (ICMJE) Guidelines, and may be required by other journals as a condition for publication. In accordance with the ICMJE guidelines, registration on ClinicalTrials.gov is required before the first participant is enrolled (i.e., signs a study consent form). For more information on the ICMJE requirements, please click here.
Please click here for a summary table comparing FDAAA/Final Rule, NIH and ICMJE requirements.
On September 16, 2016, the Department of Health and Human Services (HHS) issued a new regulation (the 2016 HHS Final Rule) and the National Institutes of Health (NIH) issued a new complementary policy (the 2016 NIH Policy) to increase the availability of information about clinical trials via ClinicalTrials.gov. The 2016 HHS Final Rule became effective on January 18, 2017 and has a compliance date of 90 days after the effective date. The NIH 2016 Policy became effective on January 18, 2017.
The 2016 HHS Final Rule clarifies requirements of reporting trials, adds additional reporting requirements, and adds specific timelines for reporting specific information. The 2016 NIH Policy extends the requirement of registering trials to all clinical trials funded in whole or in part by the NIH, regardless of the study phase or type of intervention, or whether they are subject to the 2016 HHS Final Rule.
The Responsible Party is required to submit results data to ClinicalTrials.gov for studies that require registration (i.e., as per FDAAA/Final Rule or NIH Policy). ICMJE highly encourages compliance with results entry.
The results submission will include the following information:
- Participant Flow
- Baseline Characteristics
- Outcome Measures and Statistical Analyses
- Adverse Events
- Administrative Contact (e.g., point of contact for results submitted)
The timeline for submitting results is as follows:
- Within 12 months from the Primary Completion Date for the primary outcome measure(s); and
- Within 12 months from the Study Completion Date for all other results data (e.g., secondary outcome measures and safety data).
To ensure that the results submission deadlines are correct, the record should be up to date and the completion dates listed above should accurately reflect when data collection has been completed for a study.
Please click here for definitions of the Primary Completion Date and Study Completion Date (Check under "Study Status").