Resolving and Preventing Repetitive Problems in Clinical Trials

April Bishay, BA, MBA
Senior Manager, Clinical Compliance, MedImmune

Anatoly Gorkun, MD, PhD
Chartered MCIPD, Senior Manager, Scientific & Compliance Training, MedImmune

Abstract: Clinical trial findings from audits reveal the same type of problems year after year despite the implementation of quality systems, compliance training, and corrective and preventive action plans. This article provides an overview of the root cause of these problems and how to ensure that corrective and preventive actions are addressing the actual problem rather than its symptoms. Actual case study illustrates some of the common problems in clinical trials.

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Evaluating the Protocol: Can the Clinical Research Site Really Do this Study?

Monika Gaa, MBA, CCRP
Senior Feasibility Coordinator, Nationwide Children’s Hospital

Christine Baker, BA, CCRP
Senior Regulatory Coordinator, Nationwide Children’s Hospital

Abstract: Protocol evaluation is critical to determining the feasibility of a study. This article describes the key elements for evaluating protocols for financial feasibility, recruitment, and practical application. Strategies that have worked well at Nationwide Children’s Hospital are highlighted.

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