GCP Video Series: Risk Assessment Monitoring

ClinOps Toolkit interview with Penelope Manasco Mana Consulting RBM

Risk Assessment Monitoring Assures Quality Clinical Trial Outcomes When monitoring clinical trials with a risk-based monitoring (RBM) approach, how do you determine Key Performance Indicators (KPIs)? How do you identify where the high-risk areas are? How can you assess them? How can you learn how to evaluate and interpret data? What kinds of things you…

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Medidata Talks RBM with ClinOps Toolkit for SCOPE2015 Conference

Medidata Talks RBM Big data is being generated by everything around us at all times. Every digital process and social media exchange produces it, including clinical trials. Harnessing the power of big data analytics is the latest advancement in RBM. Barbara’s talk gave practical examples on implementing RBM and extolled the benefits of how all…

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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?

Are there additional costs with risk-based monitoring of clinical trials? Clinical trials are expensive and in many case studies and presentations I (and some of my executives) have been hearing that risk-based monitoring is a potential cost-saving mechanism; that gets our attention. I have not had direct experience implementing formal targeted risk-based monitoring so today’s…

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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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Monitoring Visit Follow-Up Letters

send a confirmation letter prior to every monitoring visit

You’ll send a confirmation letter (or email if your SOPs allows it) prior to every monitoring visit, be it a pre-study qualification visit, a site initiation visit, routine monitoring visit, close-out visit, etc.  Then you’ll need to document your visit findings in a monitoring report.  Finally, you will send the principal investigator a follow-up letter…

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