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`About the Results Database - ClinicalTrials.gov
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`About the Results Database
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`Contents
`What Is the Results Database?
`Display of Results on ClinicalTrials.gov
`
`What Is the Results Database?
`The ClinicalTrials.gov results database was launched in September 2008 to implement Section 801 of the Food and Drug Administration Amendments Act of 2007
`(FDAAA) (PDF), which requires the submission of "basic results" for certain clinical trials, generally no later than 1 year after their Completion Date (see Primary
`Completion Date on ClinicalTrials.gov). The submission of adverse event information was optional when the results database was first released but was required
`beginning in September 2009. Results information for registered and completed studies is submitted by the study sponsor or principal investigator in a standard,
`tabular format without discussions or conclusions. The information is considered summary information and does not include individual patient data. The "basic" results
`information required by FDAAA 801 includes the following:
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`Participant Flow. A tabular summary of the progress of participants through each stage of a study, by study arm or comparison group. It includes the numbers of
`participants who started, completed, and dropped out of each period of the study based on the sequence in which interventions were assigned.
`Baseline Characteristics. A tabular summary of the data collected at the beginning of a study for all participants, by study arm or comparison group. These data
`include demographics, such as age and gender, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).
`Outcome Measures and Statistical Analyses. A tabular summary of Outcome measure values, by study arm or comparison group. It includes tables for each
`prespecified Primary Outcome and Secondary Outcome and may also include other prespecified outcomes, post hoc outcomes, and any appropriate statistical
`analyses.
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`Adverse Events. A tabular summary of all anticipated and unanticipated Serious adverse event and a tabular summary of anticipated and unanticipated other
`adverse events exceeding a specific frequency threshold. For each serious or other adverse event, the summary includes the adverse event term, affected organ
`system, number of participants at risk, and number of participants affected, by study arm or comparison group.
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`The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), was issued in September 2016 and is effective in January 2017.
`It expands the scope of the results database by requiring the submission of results information for trials of unapproved products and additional information for
`summarizing trial results. For more information, also see Regulations Implementing FDAAA 801.
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`ClinicalTrials.gov staff review results submissions to ensure that they are clear and informative before posting them to the Web site. However, ClinicalTrials.gov
`cannot ensure scientific accuracy. Data providers are responsible for ensuring that their submitted information is accurate and complete.
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`TO TOP
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`Display of Results on ClinicalTrials.gov
`ClinicalTrials.gov organizes information for each registered study as an integrated unit, displaying the study protocol information and, if available, the corresponding
`results information on the same page under different tabs.
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`Study Results Posted
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`When available, study results information is included in the study record under the Study Results tab. See How to Find Results of Studies for more information on
`finding results entered in the results database.
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`Results Submitted
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`After study results information has been submitted to ClinicalTrials.gov, but before it is posted, the results tab in the study record is labeled "Results Submitted."
`Results may not yet be posted because they are pending quality control (QC) review by the National Library of Medicine (NLM) or the sponsor or investigator is
`addressing QC review comments provided by NLM. For additional information, see the Results Submitted Tab section of the December 18, 2017 NLM Technical
`Bulletin article.
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`No Results Posted
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`When results are not available for a study, the results tab is labeled "No Results Posted." Results of a study may not be posted on ClinicalTrials.gov for any of the
`following reasons:
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`The study may not be subject to U.S. Federal requirements to submit results. See FDAAA 801 and the Final Rule: When Do I Need to Register and Submit
`Results?
`The study is ongoing.
`The study has been completed, but the deadline for results submission has not passed.
`The submission of results information has been delayed by the submission of a certification or a request to extend the results submission deadline. See FDAAA
`801 and the Final Rule: When Do I Need to Register and Submit Results?
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`TO TOP
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`Learn More
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`For the General Public
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`ClinicalTrials.gov Background: Learn about the mandate and mission of ClinicalTrials.gov, who supplies the study record data found on the Web site, and how to
`use the site.
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`For Study Sponsors and Data Providers
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`Why Should I Register and Submit Results?: Learn about the purpose of study registration and results submission. This page includes an overview of applicable
`laws and policies.
`How to Submit Your Results: Review the basic steps for submitting results, find out what information must be included, and learn about the review process.
`FDAAA 801 and the Final Rule: Learn about FDAAA 801 and the basic requirements for registering clinical studies and submitting results, including information
`about Responsible Parties, Applicable Clinical Trials, deadlines, and penalties.
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`This page last reviewed in March 2018
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`https://clinicaltrials.gov/ct2/about-site/results
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