Tag: protocol deviations

Feasibility Lessons From DCT and Hybrid Trials With High Deviation Rates Feasibility Lessons From DCT and Hybrid Trials With High Deviation Rates In the realm of pharmaceutical clinical trials, hybrid and decentralized clinical trials (DCTs) are transforming the way studies are conducted. However, high deviation rates can introduce significant challenges. This article presents a comprehensive,…

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Translating Deviation Root Causes Into Protocol Amendments and New SOPs Translating Deviation Root Causes Into Protocol Amendments and New SOPs The landscape of clinical trial management is an intricate realm, particularly for those involved in protocol deviations and non-compliance. With the ever-evolving regulatory frameworks existing in the US, EU, and UK, it is imperative that…

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Site and Patient Feedback Loops on Unworkable Protocol Requirements Site and Patient Feedback Loops on Unworkable Protocol Requirements In the increasingly complex landscape of clinical research, ensuring the feasibility of a clinical trial protocol is paramount to its success. Unworkable protocol requirements can lead to protocol deviations, increased costs, and diminished patient safety. This article…

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Designing Visit Schedules and Assessments That Sites Can Actually Deliver Designing Visit Schedules and Assessments That Sites Can Actually Deliver The successful execution of clinical trials, especially in the wake of challenges brought by the COVID-19 pandemic, has emphasized the importance of designing visit schedules and assessments that are both feasible and compliant. Understanding how…

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Feasibility Assessments That Reduce Deviation Risk Before First Patient In Feasibility Assessments That Reduce Deviation Risk Before First Patient In In the complex landscape of clinical trials, the protocol’s feasibility assessment plays a critical role in mitigating risks associated with protocol deviations. As clinical operations, regulatory affairs, and medical affairs professionals, it is imperative to…

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Using Deviation Data From Prior Studies to Inform New Protocol Designs Using Deviation Data From Prior Studies to Inform New Protocol Designs In clinical research, one of the pivotal considerations in designing a new protocol is leveraging the data gathered from prior studies. The strategic use of deviation data not only enhances protocol feasibility but…

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What Protocol Deviations Reveal About Feasibility and Study Design Flaws In the realm of clinical trials, adhering to the study protocol is critical for ensuring integrity, validity, and reliability. Protocol deviations—any departure from the approved clinical trial protocol—can jeopardize the quality of data collected and raise questions about the validity of the findings. This tutorial…

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