Change of Season

Springtime adverse effects can affect compliance and recruitment for clinical trials

The Change of Season May Impact the Conduct of your Clinical Trial Happy Summer Solstice. As we enjoy a long midsummer day today in San Francisco I am considering the impact that the change of seasons has on clinical trials. Most trial timelines will span several seasons so as Trial Managers, we try to predict…

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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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Powerpoint Presenter View

powerpoint presenter view: you see your speaker notes on the laptop as you project but your audience does not

[box style=”1″ close_btn=”true”] When it comes to techie tips, I’m a junkie. Hopefully there is something new for everyone in this weekly series or at least one special “Ah ha, so that is how you do it” when it for Outlook, Excel, Word, Acrobat, etc. Thanks in advance to Google, my colleagues, and the exasperated…

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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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Hidden Columns Excel

[box style=”1″ close_btn=”true”] When it comes to techie tips, I’m a junkie.  Hopefully there is something new for everyone in this weekly series or at least one special “Ah ha, so that is how you do it” when it for Outlook, Excel, Word, Acrobat, etc. Special thanks to Google, my colleagues, and the exasperated IT…

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Electronic Data Capture Wishlist

Electronic Data Capture incentive badges reward for the most mundane EDC tasks

Electronic Data Capture: Dreams, Desires, and Demands when evaluating different EDC systems Building a Wishlist This week my team at work met to brainstorm what our ideal Electronic Data Capture (EDC) system would look like and how it would perform. The brainstorm process was really fun and we covered a lot of territory. Now we…

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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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Find Files Faster

[box style=”1″ close_btn=”true”] When it comes to techie tips, I’m a junkie.  Hopefully there is something new for everyone in this weekly series or at least one special “Ah ha, so that is how you do it” when it for Outlook, Excel, Word, Acrobat, etc. Thanks in advance to Google, my colleagues, and the exasperated…

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