The Value of Centralized Monitoring

group of clinical researchers

Joanne Malia
Associate Director, Clinical Documentation Management
 Regeneron Pharmaceuticals

Abstract: Regulatory agencies are advocating for sponsors to take risk-based approaches in various clinical trial-related activities, especially in the area of monitoring. Sponsors are looking at and beginning to use centralized monitoring. This article describes centralized monitoring, regulatory and industry expectations and initiatives related to centralized monitoring, the value of centralized monitoring in enhancing data quality in clinical trials, and use and documentation of centralized monitoring,

Disclaimer: The views and opinions expressed in this article are those of the author and should not be attributed to the Society of Clinical Research Associates or Regeneron Pharmaceuticals.

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BULLSEYE: What is Targeted Monitoring All About?

Jane Ferguson, RN, MN, CCRP
Senior CRA, Westat

Abstract: Targeted monitoring is the on-site component of risk-based monitoring and focuses on the aspects of clinical research that have the most potential to impact participant safety and the credibility of the study’s results. This article provides an overview of targeted monitoring, including the need for targeted monitoring and its role in risk-based monitoring. The basics of conducting a targeted monitoring visit are covered

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A Modern CRA Perspective on the Use of Technology in Clinical Trials

By Takoda Roland, CCRA, CCRP

Founder of Philadelphia Pharmaceutical Research

Disclaimer: The examples noted in the following are all firsthand accounts of the author, but for the purpose of this article have been combined into a single site visit. The visit depicted below is an aggregate of many sites and studies and is not necessarily an exact representation. The original version was written entirely on a smartphone while flying from Philadelphia to Puerto Rico.

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Successful Collaboration Between the Clinical Research Site and the Monitor

Sharon Appelman-Eszczuk, BScN, RN, CCRP
Faculty of Medicine and Dentistry
University of Alberta  

Cathy Laferriere, BSc
Senior CRA
Quintiles Canada

Abstract: Good communication is the key to successful collaboration between clinical research site staff and the monitor, facilitating recruitment and ensuring compliance with Health Canada regulations. This article provides an overview of the monitor’s expectations of the site staff and the site staff’s expectations of the monitor. Tools to aid the site staff and the monitor in working together are provided. Scenarios describe possible issues that arise in monitor-site staff relationships and illustrate ways to resolve situations where the site staff and the monitor do not see eye to eye.

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