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Analyzing the Publication Rights Clause in CTAs
Manage episode 438964852 series 3506216
Indhold leveret af Darshan Kulkarni. Alt podcastindhold inklusive episoder, grafik og podcastbeskrivelser uploades og leveres direkte af Darshan Kulkarni eller deres podcastplatformspartner. Hvis du mener, at nogen bruger dit ophavsretligt beskyttede værk uden din tilladelse, kan du følge processen beskrevet her https://da.player.fm/legal.
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 prov
- ides 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.
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