Electronic Clinical Trial Management Systems: The Basics, Needs, and Outputs

Michael Wieczerzak
Associate Director, Clinical Quality Management, EMD Serono


Abstract: Sponsors and contract research organizations should be using electronic clinical trial management systems to efficiently oversee their trials. This article describes the basic structure of clinical trial management systems and the need for these systems. Benefits of using an integrated clinical trial management system are highlighted, including the ability to link to other systems, running reports, and outputs such as executive management reporting dashboards, listings, and merged datasets. Requirements for compliance with 21 CFR Part 11 are described.

Disclosure: The author is not writing this article on behalf of his employer.

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The Changing Landscape of Human Subjects Research

Amy Waltz, JD, CIP
Associate Director – Regulatory Affairs, Reliance, Outreach
Indiana University

Abstract: Understanding context is key to understanding the regulations and complying with regulatory requirements. This article explores the historical context and events that shaped the current human subjects protection regulations and how changes in human subjects research and public perception have impacted the proposed revisions to the human subjects protection regulations. The 2017 revisions to the Common Rule (45CFR46) and the impact of these revisions on government funded research are also addressed.

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Similarities and Differences Between Good Laboratory Practice and Good Clinical Practice

 

Milton V. Marshall, PhD, DABT, CCRP, President, Marshall & Associates

Abstract: Preclinical testing of investigational pharmaceuticals, medical devices, and biologics is necessary before human subjects can be exposed to them.  Many similarities exist between the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and the Good Clinical Practice (GCP) Guidelines (International Conference on Harmonisation E6 Good Clinical Practices), such as the requirement for a protocol, training documentation, and data retention. Differences also exist, such as the level of detail written in the requirements or whether adherence is mandatory. This article compares GLP regulations and GCP guidance, which have similar objectives: to determine the safety and efficacy of the product and document the study results for subsequent study reconstruction.

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