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Therefore, the record retention requirement must apply to all investigations from which clinical data are submitted to FDA in support of an application or submission, whether or not the investigation was sponsored by the sponsor or applicant.

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In all cases, the sponsor must publish in this registry the results of the registered research studies when they have concluded. Original articles are papers reporting the results of basic and clinical investigations that are sufficiently well documented to be acceptable to critical readers.

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If a clinical trial has more than one sponsor, all cosponsors shall assume the sponsor responsibilities established in this article, unless they decide otherwise in a contract detailing their respective responsibilities.

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Thus, they may consider not only whether a proposed study is consistent with abstract principles like autonomy and justice, but also how it compares with other studies the committee has reviewed in the past.

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The REec shall include for each study the information specified in the Annex, including the data set required in the International Clinical Trials Registry Platform of the World Health Organisation.

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