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DarshanTalks Podcast

Analyzing the Publication Rights Clause in CTAs

09 Sep 2024

Description

Today's discussion revolves around the legal clauses found in clinical trials, with a focus on Article 8, the Publication Rights Clause.The following points are discussed:Unrestricted Rights: The clause provides the Site with unrestricted rights to publish all trial data. This is excessive and could jeopardize the Sponsor's control over the integrity and proper use of the data.No Sponsor Review: There's no requirement for the Sponsor to review or approve publications, which can lead to issues with data accuracy, intellectual property rights, and compliance with regulatory standards.Intellectual Property Issues: The clause includes 'intellectual property' in the publication rights, which can lead to loss of proprietary information and patents for the Sponsor.Patient Data Exposure: Allowing publication of patient data without restrictions can breach confidentiality agreements and violate privacy laws.Support the show

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