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Webinar | Publication and Data Issues

Description

Essential Components of a Clinical Trial Agreement | Webinar Series

Clinical trials produce valuable data and knowledge that can benefit the scientific community and the public. However, they also raise complex legal and ethical issues related to the publication and dissemination of study results. In addition, there are issues involving the confidentiality of the data and interaction with the health care provider regarding protected health information, the management of study data, and the source documents including the subject medical records and any needed data sharing for verification/reproducibility. This webinar will provide an overview of the best practices and regulatory requirements for publication and data issues (confidentiality and data management) in clinical trial contracts.

Learning Objectives:

  1. Understand and apply the principles and standards for sharing clinical trial data with various stakeholders.
  2. Identify and address the legal and ethical issues related to publication rights, authorship, peer review, data quality, data ownership, intellectual property rights, data sharing agreements, and open access policies.
  3. Implement the best practices and regulatory requirements for ensuring the confidentiality, security, integrity, accessibility, and preservation of study data.
Knowledge Level: All Levels

Registration
(Deadline May 9)
Late Registration***
(After May 9)

Individual Registration
Member Rate* $99 $114
Non-Member Rate $165 $180
Group Registration**
Member/Non-Member Rate $350 $365

Register for the entire Webinar Series for one low rate!

Registration includes access to the live event, PowerPoint slides, and complimentary access to the On-Demand version for 30-days.
*To receive the member registration rate, you must an SRAI member during the event.
**All Group Attendees must be added when registering. Up to 12 attendees per group.
***If registering late, please contact registration@srainternational.org for assistance.

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Written requests for registration refunds must be postmarked on or before May 2. Cancellations submitted on or before May 2, less a $25 meeting cancellation fee. If you paid membership dues while registering, these will not be refunded; only the actual registration fees will be refunded less the cancellation fee(s). No refunds will be made after May 2. Refunds are not given for no-shows. Registration substitutions from the same institution are accepted; membership substitutions are NOT accepted. All fees will be reimbursed if the program is cancelled. In the case of a cancellation, you will be notified by SRAI from srameetings@srainternational.org.

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Contributors

  • David D. King, Retired, Senior Associate University Counsel, University of Louisville

    David retired from the University of Louisville (UofL) as of June 30, 2023, after 45 years at UofL.While Senior Associate University Counsel, David focused on research administration, technology transfer and research compliance matters in support of the offices of the Executive Vice President for Research and Innovation as well as other general university legal matters including technology procurement and privacy/data breach. Previously he served as Director of the Office of Industry Contracts, as Assistant and Associate University Counsel and various positions within Information Technology at UofL. Additionally, he was an adjunct professor in the Speed School of Engineering co-teaching a Computer Engineering and Computer Science course highlighting legal and ethical issues relative to cyberspace.

    He holds a Bachelor of Science in Applied Mathematics and a Master of Engineering in Computer Science as well as his Juris Doctor. He is or has been a member of the Association for Computing Machinery, the Louisville Bar Association, Kentucky Bar Association, American Bar Association, NCURA, SRAI, AUTM and NACUA. He has spoken at MAGI Clinical Research Conferences and the Society of Research Administrators International (SRAI) regional meetings and annual conferences including serving as a co-chair of the annual SRAI meeting in Las Vegas in 2022. As a SRAI Distinguished Faculty member and SRAI member, he continues to participate in SRAI activities such as this series of webinars and co-chair of the research law track at the annual meetings.

  • Karen Mullin, J.D., LL.M., Partner, Outside GC, LLC

    Karen A. Mullin is a partner at Outside GC LLC with over 20 years of experience in the life sciences field managing medical research issues, conflict of interest and research compliance, human subjects protection, technology development and transfer, with particular expertise in the negotiation of agreements between industry and academic sites, including clinical trial agreements, sponsored research agreements, collaboration agreements, KOL consulting agreements, confidentiality agreements, material transfer agreements and license agreements.Her in-house legal experience includes working as Chief General Counsel/Director of Technology Development for The Forsyth Institute, a non-profit medical research institute in Cambridge, MA and for Boston University as Senior Research Attorney in the Office of Research Administration on the medical campus.She also founded a small legal consulting practice representing academic institutions, hospitals, medical practices and individual physicians in their business and research relationships with industry.

    Prior to her in-house experience, Karen worked for 8 years as a litigator in law firms in Philadelphia and Boston specializing in medical and legal malpractice defense litigation as well as construction and commercial contract negotiation.Previously, she worked for one year as a clerk for the president judge of the Superior Court of Pennsylvania.

    Karen is a member of the Massachusetts, Pennsylvania and District of Columbia bars.She obtained a J.D. at Georgetown University Law Center and LL.M. with merit in international business law at the University of London.She earned a B.A. in political science, summa cum laude, from Chestnut Hill College

May 9, 2024
Thu 2:00 PM EDT

Duration 1H 0M

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