DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
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We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Analyzing the Publication Rights Clause in CTAs
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.
