About the Results Database - ClinicalTrials.gov
`3/13/23, 9:00 PM
`
`A. We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
`
`U.S. National Library of Medicine
`.
`.
`-
`ClinicalTrials.gov
`
`hi aer
`Submit Studies©
`Resources ~
`About Site »
`PRSLogin
`
`
`About the Results Database
`
`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
`{(EDAAA)(PDF), which requires the submission of "basic results” for certain clinical trials, generally no later than 1 year after their Completion Date (see Primary
`CompletionDateon 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 sponsoror 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 801includes the following:
`« Participant Flow. A tabular summary ofthe 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. Atabular summary ofthe data collected at the beginning of a study forall 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. Atabular summary of Outcome measure values, by study arm or comparison group.It includes tables for each
`
`analyses.
`* Adverse Events. A tabular summary of all anticipated and unanticipated Serious adverse event and a tabular summary ofanticipated 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.
`
`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 ofthe 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.
`ClinicalTrials.gov staff review results submissionsto 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.
`
`
`
`Display of Results on ClinicalTrials.gov
`CiinicalTrials.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 underdifferent tabs.
`
`Study Results Posted
`Whenavailable, study results informationis 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.
`Results Submitted
`
`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 pendingquality contro! (QC) review by the National Library of Medicine (NLM)or the sponsororinvestigator 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.
`
`No Results Posted
`
`Whenresults 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 ofthe
`following reasons:
`* The study may not be subject to U.S. Federal requirements to submit results. See FDAAA 801 and the Final Rule: When Do | 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 | Need to Register and Submit Results?
`
`
`
`Learn More
`
`For the General Public
`
`* CiinicalTrialsgov 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.
`
`For Study Sponsors and Data Providers
`* Why Should | Register and Submit Results?: Leam 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.
`« EDAAA 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.
`
`This page last reviewed in March 2018
`
`https://clinicaltrials.gov/ct2/about-site/results
`
`1/1
`
`Samsung Bioepis Exhibit 1022 - Page 1
`Biocon Exhibit 1022 - Page 1
`
`