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GxP Lifeline

Showing items tagged as GCP

  • 2021-bl-gcp-violations_132x132

    Good Clinical Practices and 5 Common GCP Violations in Clinical Studies

    Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions, including drugs, biologics, devices, and therapy protocols. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. Good Clinical Practices (GCPs) provide a platform for the quality of the data and a unified standard for the conduct of clinical trials. Understand the most common issues cited in U.S. Food and Drug Administration (FDA) inspections of clinical trials, and know how to avoid them.

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  • 2020-bl-gcp-compliance-hack_132x132

    GCP Compliance Hack: How to Avoid the Most Common Warning Letter Trigger

    The most frequently cited good clinical practice (GCP) violation is a failure to adhere to a study’s investigational plan. But there’s a straightforward solution to your protocol compliance woes. Hint: it doesn’t involve the disconnected, mostly paper-based systems currently used to manage clinical trials.

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  • What Does Risk-Based Monitoring Mean for QA Auditing?

    By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (QA) teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

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  • From Good to Great – The One Skill Great CRAs Possess

    Don’t get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA. 

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  • Partnering with Quality Professionals Worldwide

    MasterControl has grown our reach significantly over the last 10 years—from a small provider of a narrowly focused document control product to one of the largest organizations in the world focused on helping quality and compliance professionals achieve their purpose. I have met with many of the world’s top quality professionals over the past 10 years and I have been amazed by their devotion and commitment. I have recently found myself asking the question: What drives these dedicated people? Why are they so passionate about their jobs? I believe I have found the answer and it has had a strong effect on how I view MasterControl’s mission.

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