Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-516-L04-P; CME 2.75; IACET 2.75; RN 2.75
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With any system used for clinical research, the technology must comply with current research laws, regulations, and statutes. However, blockchain developers and operators are often unfamiliar with clinical research regulations and related data and technology standards. Even for stakeholders aware of regulatory requirements, there is uncertainty about regulatory research interpretations applied to blockchain.
In this course, we will provide an overview of this emerging technology: how it is being used in healthcare and life sciences, where it is being explored for future use, how it operates from a non-technical perspective, and the risks, benefits, and trade-offs of its use in the lifesciences.
We will encourage researchers and administrators exploring blockchain applications to build regulatory compliance requirements into their processes so they can meet required controls and safeguards. Further, when blockchain systems are used to collect, store, and distribute data for research purposes, regulatory agencies also expect detailed compliance documentation, such as initial and ongoing testing, validation, methods for updates and upgrades, training, physical security, access controls, and policies that pertain to all of these things. Blockchain developers should also provide appropriate documentation to organizations using the technology for the organizations’ due diligence.
While our course focuses primarily on regulations in the United States, the concepts of patient-centric design, data integrity, appropriate informed consent, and privacy apply to all research settings. Ultimately, we aim to provide life sciences stakeholders with a stronger understanding of responsibilities for compliant implementation and typical uses.
No prior knowledge of blockchain technology is required for this short course.
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
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DIA 2021 Who should attend? This short course is designed for: Lifescience leaders, researchers, regulators, administrators, technologists and informaticists. We assume a functional knowledge of lifesciences research and related regulations. We will provide a beginners-level look at this technology and how it can innovate and accelerate life sciences research.
Learning Objectives Describe what blockchain is, how it operates from a non-technical perspective, and how it is currently being used in lifesciences research; Discuss approaches that regulatory agencies have taken toward blockchain technologies in contract, drug, and device development; Design documentation / testing strategies for IRB submissions, privacy laws, and electronic record/signature regulations.
