Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices.
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."
You are responsible for submitting to ClinicalTrials.gov if your study meets these four criteria:
1. Your study is an applicable clinical trial or is an NIH-funded clinical trial. Studies in one or more of the following categories must register on ClinicalTrials.gov:
- Drug clinical trials that are controlled clinical investigations, other than phase I trials, of drugs or biological products subject to Food and Drug Administration (FDA) regulation.
- Device clinical trials that are either clinical studies of health outcomes with an FDA approved Investigational New Device (IDE) against a control in human subjects, or pediatric postmarket surveillance as required under section 522 of the Federal Food, Drug, and Cosmetic Act. Feasibility studies or tests of prototype devices where the primary outcome relates to feasibility and not to health outcomes are excluded.
- NIH-funded research studies 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. All NIH-funded clinical trials are required to register regardless of study phase, type of intervention, or whether they are subject to FDA regulation.
2. You are the sponsor or responsible party for this clinical trial. A sponsor is a person who initiates a clinical investigation. The responsible party is the principal investigator if so designated by a sponsor, grantee, contractor, or awardee. The responsible party must be responsible for conducting the trial and have access to and control over the data with the right to publish the results. If you are unsure if you are the responsible party, contact your funding agency to determine the responsible party. If you have an NIH-funded clinical trial, the grant recipient or investigator is responsible for registering.
3. Your trial is ongoing as of December 26, 2007 or any date thereafter.
4. You checked ClinicalTrials.gov and your study is not registered. Duplicate submissions to ClinicalTrials.gov should be avoided. If your study is already registered, then either the sponsor or their deligated responsible party has already registered the trial. If you believe that you should have been the responsible party for registering, contact your funding agency to determine how the study was registered and if you have any responsibility for posting results in the future.
If you are responsible for registering, visit the How to Register Your Study section of ClinicalTrials.gov.
For clinical trials initiated after September 27, 2007, the deadline to register is 21 days after the first patient is enrolled.
Results submission is required for the following types of research:
- NIH-funded clinical trials
- Clinical trials that were required to be registered under FDAAA 801 and that study drugs, biologics, or devices that are approved, licensed, or cleared by FDA.
If you are responsible for submitting results, visit the How to Submit Your Results section of ClinicalTrials.gov
For applicable clinical trials that are subject to 42 CFR 11.42, the standard submission deadline for results information is no later than 1 year after the study's Primary Completion Date, as described in 42 CFR 11.44(a) of the final rule.
The regulations provide for the delayed submission of results information under certain conditions (see 42 CFR 11.44(b)) with certification if the responsible party is seeking approval, licensure, or clearance of a new use being studied for a product that previously has been approved, licensed, or cleared by the FDA. For applicable clinical trials with a Primary Completion Date on or after January 18, 2017, the final rule in 42 CFR 11.44(c) also provides for the delayed submission of results information under certain conditions with certification if the responsible party is seeking initial approval, licensure, or clearance for the studied product. The deadline for the delayed submission of results information as specified in 42 CFR 11.44(b) or 42 CFR 11.44(c) is 30 calendar days after the earliest of specific events described in each provision, with a maximum deadline for delayed results information submission of 2 years after the date of submission of the certification. Specific deadlines are also described in 42 CFR 11.44(d) of the final rule for the submission of partial results information. An extension for good cause may be requested under conditions specified in 42 CFR 11.44(e) of the final rule. The preamble explains that such requests will be granted in limited circumstances (81 FR 65076-79).
Uploading to ClinicalTrials.gov has become easier
per NIH posting dated 3/7/2019. To make registration easier, eRA Human Subjects System (HSS) has a new feature that will allow applications and recipients to export study record entries as an XML file that are included in both systems directly into ClinicalTrials.gov Protocol Registration and Results System. Step-by-step instructions and more information is availalbe at How to Upload Studies to ClinicalTrials.gov and video is available at HSS:How to Export Study Record Data
Clinical Trials News from National Institutes of Health:
Clinical Trial E-Protocol Tool and Template DocumentsThe electronic protocol writing tool aims to facilitate the development of two types of clinical trials involving human participants. The first type of trials are Phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application.
NIH developed a second protocol template to help behavioral and social science researchers prepare research protocols for human studies measuring a social or behavioral outcome or testing a behavioral or social science-based intervention.
Both templates found in the electronic protocol tool meet the standards outlined in the International Council on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6). These are international standards of good clinical practice that apply to all clinical trials, and their goals are to ensure research integrity and protect human subjects. In addition, use of the electronic protocol tool allows researchers to interface directly with clincialtrials.gov.
Questions about the tool can be sent to SciencePolicy@od.nih.gov.
Final "Phase 2 and 3 Clinical Trial" Template Documents
- Word Version of Final Template
- NIH Guide Notice
- NIH Director's Statement
- Under the Poliscope blog
- FDA Voice blog
Final "Behavioral and Social Sciences Research Involving Humans Template" Documents