Leveraging eSource as a Study Manager for Remote Monitoring 

By:  Takoda Roland, CTM, CCRA, Associate Director of Clinical Operations, Sitero

 

I have long been a proponent of the potential of eSource and its advantages in clinical trials.  From my experience as a CRA (Clinical Research Associate) I first wrote about eSource in Nov 2018 SOCRA and Jan 2019 ACRP which enabled me to see that clinical research was only just scratching the surface on leveraging eSource to fundamentally change the way we are monitoring clinical trials.  At the time I did not expect to be find myself in a position to make a meaningful shift towards remote monitoring.  Several years later while working as a CTM (Clinical Team Manager) COVID forced CROs (Contract Research Organizations) to rethink their monitoring paradigm.  Drawing from both my own and my team’s experience with eSource, our study was able to successfully implement a remote monitoring process to mitigate the issues of running a clinical trial during a pandemic.  Even as someone who had long advocated for remote monitoring using eSource, I found myself astounded at the success our team achieved.   

Continue reading Leveraging eSource as a Study Manager for Remote Monitoring 

Career Progression in Clinical Research: Transitioning from a Clinical Research Coordinator to a Monitoring Clinical Research Associate (CRA)

Thomas Boothby, MS, CCRP CRA II, Boston Scientific

Abstract: Research coordinators may transition to clinical research associates/monitors during their careers. This article provides an overview of how to determine whether it is the right time to make this transition, how to evaluate current competencies and gaps that must be filled in order to make this transition, and how to address needs during the on-boarding process. A roadmap in the form of a checklist is provided to help make the transition from research coordinator to clinical research associate (CRA) a smooth one.

Disclosure: The author has a relevant financial relationship with respect to this article with Boston Scientific, where he is employed as a monitoring CRA.

Continue reading Career Progression in Clinical Research: Transitioning from a Clinical Research Coordinator to a Monitoring Clinical Research Associate (CRA)

Operationalizing the Serious Adverse Event (SAE) Process at Clinical Research Sites

Operationalizing Serious Adverse Event Process

Tracy Popp, MBA
Previously: Director, Research Financial Operations Norton Healthcare, Inc.
Currently: Senior Director of Clinical Research, Tampa General Hospital

Abstract: It is important for clinical research sites to operationalize the serious adverse event (SAE) process beyond regulatory and clinical. Norton Healthcare, Inc. has developed policies and a workflow for operationalizing SAEs, including clinical, legal, billing, accounting, and budgeting capture. This article provides an overview of the way in which Norton Healthcare has done this as well as how other sites can also operationalize SAEs.

Continue reading Operationalizing the Serious Adverse Event (SAE) Process at Clinical Research Sites

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.

Continue reading The Value of Centralized Monitoring

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

Continue reading BULLSEYE: What is Targeted Monitoring All About?

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.

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

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.

Continue reading Successful Collaboration Between the Clinical Research Site and the Monitor