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Contracting Considerations in Research & Innovation

This presentation discusses the various contractual arrangements involved in clinical trials, including Confidentiality Disclosure Agreements (CDA), Material Transfer Agreements (MTA), Clinical Trial Agreements (CTA), and Data Transfer Agreements (DTA). It covers considerations for both commercial and non-commercial trials, investigator-initiated trials, and national initiatives. The talk also addresses legal and jurisdictional aspects, intellectual property rights, funding conditions, indemnity and insurance, data protection, and more.

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Contracting Considerations in Research & Innovation

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  1. Contracting Considerations in Research & Innovation R&D Forum, 6 May 2015 Dr Karen Underwood R&D Senior Contracts Manager University Hospital Southampton NHD Foundation Trust

  2. Clinical Trial Contractual Arrangements CDA MTA CTA DTA • Sponsor Trial Site Sponsor • Commercial Trials • Non-Commercial Trials • Investigator Initiated Trials

  3. Commercial Trials • CDA • One Way – protect sponsor Confidential Information • Term • Survival of confidentiality obligations • Law / jurisdiction • IP • FOIA / law • Liability / injunctive relief

  4. Commercial Trials • CTA • Model with amendments • Often non-UK sponsor • Research governance • Indemnity • Equipment • Clinical trial subjects • MTA + template • DTA + template

  5. Non-Commercial Trials • CDA – often not put in place • CTA • US / Non-UK Sponsor • Research governance / terminology • FDA requirements for investigators • Funding conditions • Law/jurisdiction • Indemnity / insurance • Data Protection • Human Tissue

  6. Non-Commercial Trials • Collaboration Agreement • Compatible with grant funding • IP – ownership, access and commercialisation • Responsibilities • Site agreements reflect terms of collaboration agreement

  7. Material Transfer Agreement • Need to ensure recipient complies with: • Patient consents • Protocol • Ethical Approval • Human Tissue Act

  8. Data Transfer Agreement • Data transfer outside EEA • 8th Principle of data protection act • Is it personal data • Is the country recognised by EU as having adequate protection? • US – on safe harbour list? • Technical measures? • model contract clauses?

  9. Investigator Initiated Trials • Grant Contract • Funding terms and conditions • IP Ownership & Commercialisation • Data Access • Publication / Publicity • Acknowledgement • Notification

  10. Investigator Initiated Trials • CTA with company not sponsor • Funding / product • IP ownership • Data access • Indemnity for product • Acknowledgement • Conflict of interests • Compatability with grant contract

  11. National Initiatives • R&D Forum • Guidance on CDA • Model CDA • HRA Approval • Model Agreements - suite

  12. Questions ??

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