Tag: clinical operations

Risk-Based Monitoring Under ICH E6(R3): From Theory to Execution

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Risk-Based Monitoring Under ICH E6(R3): From Theory to Execution Risk-Based Monitoring Under ICH E6(R3): From Theory to Execution In the fast-evolving landscape of clinical trials, particularly within oncology clinical research, the emphasis on maintaining high-quality standards of data and patient safety is paramount. ICH E6(R3) introduces a shift toward Risk-Based Monitoring (RBM) principles that enhance…

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Monitoring per GCP (On-site/Remote)

Transitioning Participants to Standard of Care or New Studies

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Transitioning Participants to Standard of Care or New Studies In the realm of clinical research, transitioning participants from clinical trials to standard of care or enrolling them in new studies is a critical process that demands meticulous planning and execution. This article aims to provide clinical operations, regulatory affairs, and medical affairs professionals with a…

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Close-Out Visits & Archiving

Decommissioning Study Systems and Vendor Contracts at Close-Out

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Decommissioning Study Systems and Vendor Contracts at Close-Out Effective close-out procedures are a critical phase in the lifecycle of clinical trials. The process of decommissioning study systems and managing vendor contracts at close-out ensures compliance, safeguards data, and prepares the trial for regulatory inspection. This tutorial serves as a step-by-step guide for clinical operations, regulatory…

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Close-Out Visits & Archiving

Integrating Source Data Requirements Into Protocol and SAP

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Integrating Source Data Requirements Into Protocol and SAP Integrating Source Data Requirements Into Protocol and SAP In the realm of applied clinical trials, the integration of source data requirements into the study protocol and statistical analysis plan (SAP) constitutes a critical aspect of compliance with regulatory standards. As clinical trials evolve, regulatory bodies such as…

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Source Data & ALCOA++

Source Data Archiving and Long-Term Integrity Under GCP

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Source Data Archiving and Long-Term Integrity Under GCP This comprehensive tutorial provides clinical operations, regulatory affairs, and medical affairs professionals with step-by-step guidance on the best practices surrounding source data archiving and ensuring long-term integrity under Good Clinical Practice (GCP) regulations. Special attention will be paid to the role of data safety monitoring boards (DSMB)…

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Source Data & ALCOA++

Close-Out Documentation That Satisfies Auditors and Inspectors

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Close-Out Documentation That Satisfies Auditors and Inspectors Close-Out Documentation That Satisfies Auditors and Inspectors In clinical trials, the close-out phase concludes the research and is critical for ensuring compliance with regulations set by governing bodies such as the FDA, EMA, and MHRA. Proper close-out documentation serves as proof of compliance and is essential for any…

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Close-Out Visits & Archiving

Managing Biobank and Sample Storage Commitments at Study End

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Managing Biobank and Sample Storage Commitments at Study End In the complex landscape of clinical research, managing biobank and sample storage commitments at the study end can be a daunting task for professionals in clinical operations, regulatory affairs, and medical affairs. Effective management is crucial not only for regulatory compliance but also for ensuring that…

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Close-Out Visits & Archiving

Using ALCOA++ Principles in Vendor and System Qualification

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Using ALCOA++ Principles in Vendor and System Qualification In the context of clinical trials, the principles defined by ALCOA++ serve as critical guidelines for ensuring the integrity of data collection, processing, and reporting. This step-by-step tutorial provides a framework for clinical operations, regulatory affairs, and medical affairs professionals involved in the qualification of vendors and…

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Source Data & ALCOA++

Training Site Staff on ALCOA++ Using Practical Examples

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Training Site Staff on ALCOA++ Using Practical Examples Training Site Staff on ALCOA++ Using Practical Examples As clinical trials continue to evolve, the importance of ensuring data integrity extends beyond traditional practices. One such approach is the ALCOA++ principle, which emphasizes that source data must be Attributable, Legible, Contemporaneous, Original, Accurate, and complete. This step-by-step…

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Source Data & ALCOA++

Remote Close-Out Models: When and How to Use Them

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Remote Close-Out Models: When and How to Use Them In the rapidly evolving landscape of clinical research, the efficiency and effectiveness of close-out visits are pivotal for the successful completion of clinical trials. As globalization and technological advancements continue to transform the clinical trial ecosystem, remote close-out models have emerged as a practical solution. Particularly…

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Close-Out Visits & Archiving