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`CELLTRION - EXHIBIT 1069
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`1/20/2021
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`ClinicalTrials.gov Background- ClinicalTrials.gov
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`registered and additional trial registration information to be submitted. The law also requires the submission
`
`of results for certain trials. This led to the developmentof theClinicalTrials.gov results database, which
`contains summaryinformation on study participants and study outcomes, including adverse events. The
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`results database was madeavailable to the public in September 2008. FDAAA 801 also established
`
`in January 2017.
`
`An account of the development and expansionof ClinicalTrials.gov in response to changesin policies and
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`laws is provided on the History, Policies, and Laws page.
`
`Searching ClinicalTrials.gov does not require registration or personal identification. Because
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`ClinicalTrials.gov is a Government Website, it does not host or receive funding or advertising from
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`commercial entities or display commercial content.
`
`TO TOP
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`WhatInformation Can I Find on ClinicalTrials.gov?
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`Each ClinicalTrials.gov record presents summary information about a study protocol and includes the
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`following:
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`e Disease or condition
`
`e
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`Intervention (for example, the medical product, behavior, or procedure being studied)
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`penalties forfailing to register or submit the results oftrials. In September 2016, HHS issued the Final Rule
`for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifying and expanding
`the registration and results information submission requirements of FDAAA 801. This regulation takes effect
`
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`e Title, description, and design of the study
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`e Requirements for participation (eligibility criteria)
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`e Locations where the study is being conducted
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`e Contact information for the study locations
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`e Links to relevant information on other health Websites, such as NLM's MedlinePlus® for patient health
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`information and PubMed®forcitations and abstracts of scholarly articles in the field of medicine
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`Somerecordsalso include information on the results of the study, such as:
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`e Description of study participants (the numberof participants starting and completing the study and their
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`demographic data)
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`e Outcomesof the study
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`e Summaryof adverse events experienced by study participants
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`Thefull history of the changes made to a record can be accessedby viewing the archival version of the
`record on the ClinicalTrials.gov archive. Once a study is registered on thesite, the information aboutit is not
`removed.
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`https://www.clinicaltrials.gov/ct2/about-site/background
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`TO TOP
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`1/20/2021
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`ClinicalTrials.gov Background- ClinicalTrials.gov
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`What Can | Do on This Site?
`
`Find and view clinical studies. Conduct basic and advanced searchesofclinical study records; browse
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`studies; and search studies by topic, country, or region. See the Find Studiessectionofthesite.
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`Learn more aboutclinical research. Find out howclinical studies are conducted and who can
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`participate. See Learn About Studies.
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`Managestudy records. Find out how to submit and maintain study records, access the Protocol
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`Registration and Results System, and enter summary information about study protocols and results. See
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`the Submit Studies section ofthe site.
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`Use site tools and data. View statistics on registered studies or download study recordsfor analysis.
`
`See the Resourcessection ofthe site.
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`This page last reviewed in January 2018
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`https://www.clinicaltrials.gov/ct2/about-site/background
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