Tag: informed consent

IRB/IEC Meeting Preparation: FAQs, Investigator Obligations and Documentation IRB/IEC Meeting Preparation: FAQs, Investigator Obligations and Documentation Introduction to IRB/IEC Meetings In the realm of clinical trials, the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) plays a pivotal role in safeguarding the rights and welfare of trial participants. As regulatory bodies, they ensure that…

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Central vs Local IRB Models: Operational Pros and Cons for Sponsors and CROs In the field of clinical research, understanding the operational frameworks in which studies are conducted is essential for compliance with regulatory guidelines and ethical standards. One significant aspect of this is the choice between Central and Local Institutional Review Board (IRB) models….

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Sponsor Oversight of Site-Level IRB/IEC Compliance: Roles and Metrics Sponsor Oversight of Site-Level IRB/IEC Compliance: Roles and Metrics In the complex landscape of clinical research, ensuring that sites adhere to ethical standards monitored by Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) is paramount. This comprehensive guide provides a step-by-step approach for clinical operations,…

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IRB/IEC Documentation for Inspection Readiness and TMF Quality Ensuring compliance and quality in clinical trials is a multifaceted process, critical for the integrity of data and the overall success of the trial. This article provides a comprehensive step-by-step guide for clinical operations, regulatory affairs, and medical affairs professionals focusing on Institutional Review Board (IRB) and…

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Continuing Review in High-Risk and Vulnerable Population Studies Continuing review processes are crucial for maintaining ethical standards and regulatory compliance in clinical trials, especially when studies involve high-risk and vulnerable populations. The importance of systematic monitoring through methodologies such as remote monitoring in clinical trials is gaining traction, and this article aims to provide a…

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What IRBs and IECs Look for in Risk–Benefit Justifications Understanding IRB and IEC Expectations for Risk–Benefit Justifications As clinical trials evolve in their complexity and methodology, the role of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) has become increasingly critical in assessing the ethical validity of proposed research. For clinical operations, regulatory affairs,…

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Digital Portals and e-Submissions: Streamlining IRB/IEC Workflows Digital Portals and e-Submissions: Streamlining IRB/IEC Workflows In the dynamic landscape of clinical research, particularly in psoriatic arthritis clinical trials, it becomes critical to ensure efficient and compliant processes for Institutional Review Board (IRB) and Independent Ethics Committee (IEC) submissions and continuing reviews. The advent of digital portals…

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Major and Minor Protocol Amendments: When and How to Notify IRBs and IECs Major and Minor Protocol Amendments: When and How to Notify IRBs and IECs Effective management of protocol amendments is crucial in ensuring the integrity of clinical trials and the protection of trial participants. This guide provides a comprehensive overview of the procedures…

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