Mobile Medical Devices

Mobile Medical Devices

By: Jonathan C. Young, PhD, MS, CIP, CCRP Senior Research Regulatory Operations Analyst Rush University Medical Center

Abstract: The use of mobile medical devices in clinical research is increasing significantly. This article provides an overview of regulations and guidance related to mobile medical devices including mobile apps. Possible risks and controversy that may arise from the use of mobile medical devices and how to improve submissions to institutional review boards for research involving mobile medical devices are also discussed. Examples of institutional review board review of real studies involving mobile medical devices at Rush University Medical Center are provided.

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Improving Communication in Clinical Research

Improving Communication in Clinical Research
By: Anatoly Gorkun, MD, PhD, Chartered MCIPD
            Senior Manager, Global Clinical Development, PPD UK

Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.

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