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X-WR-CALNAME:The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
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X-WR-CALDESC:Events for The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
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SUMMARY:Operationalizing ICH E6(R3) Data Governance
DESCRIPTION:Webinar\n\n\n\n\n\n\n\n\n\nICH E6(R3) introduces\, for the first time\, a dedicated data governance section that provides guidance on the appropriate management of data integrity\, traceability\, and security to enable accurate reporting\, verification\, and interpretation of clinical trial-related information. Data governance addresses how data are managed\, protected\, and maintained throughout the data lifecycle.   \n\n\n\nWhy is data governance important for clinical trial quality?   \n\n\n\nEffective\, risk-proportionate data governance ensures the information generated in the clinical trial is fit for purpose and sufficient to provide confidence in the trial’s results and support good decision-making.  \n\n\n\nHow do sponsors and investigators achieve effective data governance?   \n\n\n\nThis webinar brings together three members of the ICH E6(R3) Expert Working Group who wrote the guideline to break down Section 4\, Data Governance\, of the E6(R3) guideline. Together\, they will discuss:  \n\n\n\n\nWhy was this section added\, and what are the foundational concepts of clinical trial data governance\, including key principles and new terminology \n\n\n\nHow do trial design\, protocol development\, and trial conduct influence risk-proportionate management of the data throughout the trial? \n\n\n\nWhat are the sponsor and investigator roles and responsibilities related to data governance? \n\n\n\nHow is data traceability maintained throughout the data lifecycle \n\n\n\nHow are confidentiality\, blinding\, computerized systems\, and key decision-making processes protected throughout the data lifecycle\, recognizing that vulnerabilities can arise at each data lifecycle stage \n\n\n\n\nPanelists:   \n\n\n\n\nLisbeth Bregnhøj\,  Senior Auditor\, ObelysQ\, former Senior GCP and Pharmacovigilance Inspector at the Danish Medicines Agency.\n\n\n\nAndy Fisher\, Lead Senior GCP Inspector\, UK Medicines and Healthcare products Regulatory Agency; and  \n\n\n\nCheryl Grandinetti\, Associate Director for Clinical Policy\, Division of Clinical Compliance Evaluation\, Office of Scientific Investigations\, Office of Compliance\, CDER\, FDA\, and FDA Topic Lead for ICH E6(R3);  \n\n\n\n\n\nSarah White\, Executive Director of the MRCT Center\, will moderate. \n\n\n\n\nThe webinar builds on Data Governance (Module 3) of the MRCT Center’s free ICH E6(R3) training.  \n\n\n\n\n\n\n\n    \n    Register Now\n    \n\n\n\n\n\n\n\nInterpretation and Application of ICH E6(R3): Good Clinical Practice Guideline\n\n\n\n\n\nImplementing ICH E6(R3): Practical Risk-Proportionate Strategies for IRBs\, Investigators\, and Study Teams\n\n\n\n\n\nGood Clinical Practice in Practice: Implementing ICH E6(R3)\n\n\n\n\n\n			    October 29\, 2022 \n    Training & Education ›
URL:https://mrctcenter.org/tribe-events/operationalizing-ich-e6r3-data-governance/
CATEGORIES:Webinar
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DTSTART;TZID=America/New_York:20261201T130000
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SUMMARY:Joint Task Force for Clinical Trial Competency (JTF) Global Biannual Meeting
DESCRIPTION:Meeting\n\n\n\n\n\n\n\n\n\n\n\n\n\nThe Joint Task Force for Clinical Trial Competency (JTF)\, anchored at the MRCT Center\, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach\, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively. \n\n\n\nOur international team of investigators\, educators\, and clinical research professionals has developed and/or utilizes a framework that defines the knowledge\, skills\, and attitudes necessary for conducting safe\, ethical\, and high-quality clinical research. \n\n\n\nJoin us on December 1\, 2026\, 1:00-3:00 PM for the Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting to hear about global perspectives on implementing the JTF Framework.  \n\n\n\nTo learn more about the JTF Framework: https://mrctcenter.org/clinical-trial-competency/framework/overview/ \n\n\n\nAll registrants will receive slides and a meeting summary after the meeting. This event is free.  \n\n\n\n    \n    REGISTER HERE
URL:https://mrctcenter.org/tribe-events/joint-task-force-for-clinical-trial-competency-jtf-global-biannual-meeting-6/
CATEGORIES:Meetings
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DTSTART;TZID=America/New_York:20261208T100000
DTEND;TZID=America/New_York:20261208T123000
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SUMMARY:Ethical Dimensions of Implanted Neurotechnologies
DESCRIPTION:Topic: Ethical Dimensions of Implanted Neurotechnologies \n\n\n\nAbstract: Implanted neurotechnologies hold promise for treating neurological and psychiatric disorders\, restoring impaired functions such as speech and movement\, and extending human capabilities through brain-computer interfaces. Recent advances in artificial intelligence have accelerated clinical trials of neural implants\, including first-in-human studies of devices that enable people with quadriplegia or amyotrophic lateral sclerosis to control a computer cursor or assistive devices with their thoughts.  \n\n\n\nAt the same time\, neurally implanted devices raise distinctive ethical challenges. The data these devices generate—real-time neural recordings that may reflect a participant’s intentions\, thoughts\, or affective states—pose complex questions of neuroprivacy and data protection. The ability of these devices to “read your mind” and to influence action challenges traditional notions of privacy\, accountability\, and moral culpability. Traditional research ethics concerns about device failure\, migration\, and abandonment; unintended psychiatric or neurological changes that may be irreversible; consent among participants whose disability affects communication or decision-making capacity; and therapeutic misconception persist. Finally\, these ethical challenges appear in a different light when viewed in the context of medically important neuropsychiatric research versus non-medical neuroaugmentation or human cognitive enhancement. \n\n\n\nHow do we ensure that research with implanted neurotechnologies proceeds responsibly\, honoring both the therapeutic promise of these technologies and the vulnerabilities of those who participate\, while limiting work that may be morally problematic? \n\n\n\n\n\nThis meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor\, click here.
URL:https://mrctcenter.org/tribe-events/ethical-dimensions-of-implanted-neurotechnologies/
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