Advice for Site Monitor Visits Every Clinical Research Coordinator Should Know

As a clinical study coordinator, what should I do before a Clinical Research Associate (my CRA) arrives for monitoring? Planning Prior to Monitoring Visit (MV) Schedule a mutually convenient date and time to conduct the MV with the CRA, assuring the availability of study team as required Collate the study subject files, Screen Fail subject…

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GCP Video Series: Risk Assessment Monitoring

ClinOps Toolkit interview with Penelope Manasco Mana Consulting RBM

[box style=”0″] Please subscribe to the Good Clinical Professionals series on our YouTube channel (link).  Daron Scott, Senior Contributor at ClinOps Toolkit will bring you new videos every month.  He is asking hard-hitting questions to find out what it takes to be an extraordinarily effective Good Clinical Pro!  Connect with Daron on Twitter @Scott_Daron In…

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Medidata Talks RBM with ClinOps Toolkit for SCOPE2015 Conference

[box style=”0″] Our First Interview in the GCP Series Our 2015 ClinOps Toolkit video interview series introduces you to two of our favorite industry thought leaders and Good Clinical Professionals (GCPs)! Kyle Given and Barbara Elashoff of Medidata kindly agreed to sit down with us for an interview to discuss risk-based monitoring (RBM) and Barbara’s…

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Six Strategies to be a More Effective Monitor

Become a More Effective Monitor Six Strategies to be a More Effective Monitor On-Demand Webinar by Patty Kasper, MS, CCRA When I first became a CRA, I took a course led by expert in clinical monitoring, Patty Kasper, MS, CCRA. Today, almost a decade later, I still regularly reference the materials and Patty’s straightforward methods for…

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Virtual Meetings with Your Remote CRAs

Luizinha Monteiro

Luizinha Monteiro is a Sr. Clinical Research Associate living in Oakland, California.  Luizinha has nearly 10 years experience monitoring clinical drug trials. Prior to her transition to a CRA, Luizinha worked as a clinical research study coordinator for more than 5 years. Her valuable perspective as a coordinator and broad therapeutic experience make her uniquely…

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Risk-Based Monitoring Guidance

Risk-Based Monitoring Are we having a fight

Risk-Based Monitoring Guidance August 2013 The FDA recently issued risk-based monitoring guidance in August 2013.  This guidance for sponsors of investigational new drug/device trials details a risk-based monitoring approach to monitoring safety and efficacy in studies. As with all guidances, it isn’t a flat out endorsement, recommended procedure document, or enforceable requirement list; “sponsors can…

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The Lead CRA Interview with an Independent CRA

Annmarie loves boating on lake michigan when she is not busy as a CRA

An Interview with an Independent CRA The Lead CRA asks: Annmarie, when you show up on site you always have your objectives planned out. What kind of prep work do you complete prior to visiting a clinical site for the first time? Annmarie: I send a detailed confirmation letter indicating my goals and expectations. So that…

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Costs of Risk-Based Monitoring

Are there additional costs with risk-based monitoring of clinical trials?

[box style=”2″ close_btn=”true”] Money Matters: Payday again, so this topic falls under the theme of trial fiscal management. Like a steady paycheck, you can look for blog updates on financial topics in this semi-monthly series. [/box] Are there additional costs with risk-based monitoring of clinical trials? Clinical trials are expensive and in many case studies…

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Risk-based Monitoring Fatigue

I had Risk-Based Monitoring Fatigure and I thought about starting a support group

If I hear “risk-based” one more time… When it comes to monitoring clinical trials, I feel like “risk-based” is the buzz word for 2013. Every time I heard the phrase I was having an emotional response: a mix between anger, annoyance, and amusement. I had more or less refused to write about it as a…

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Risk Assessment in Monitoring

medidata risk assessment in clinical trials

Clinical trial monitoring necessitates timely and accurate risk assessment. Risk assessment has become particularly relevant given that industry pioneers are increasingly and aggressively considering a risk-based monitoring paradigm. This paradigm is endorsed by consortiums like TransCelerate and supported by guidance issued from regulatory agencies such as FDA and EMA. So, how should a CRA assess…

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