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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PIs on Pharma’s Payroll

Who is being paid to conduct clinical trials? A review of Investigator Payments and Sunshine Act buzz

[box style=”2″ close_btn=”true”] Money Matters: It is 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] Which Clinical Investigator’s are on Pharma’s Payroll? Yeah, I’ve Heard of the Sunshine Act. What is it again?…

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Decluttering my Desktop

computer desktop cluttered? I recommend Fences desktop organization software

[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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Pediatric Clinical Trials

an increase in the conduct of pediatric trials

I have not had the opportunity to work on a pediatric trial, however in the past year several people in my network have worked on these trials. I thought it was interesting that more of my old colleagues were working on clinical trials and after a capabilities presentation from ReSearch Pharmaceutical Services last week I…

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Document Readability

[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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Financial Disclosure Forms

financial disclosure forms in clinical trials

Financial Disclosure Forms Updated Guidance In February the FDA issued industry guidance for the collection of financial disclosures.  I’ve summarized and called out a few of the sections I found most interesting.  There were certainly some items I hadn’t thought about in a while so the refresher and clarifications were helpful and the appendix of Q&A was…

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Worthwhile Webinars

Worthwhile Webinars: be credentialed, know your audience, have learning objectives

I’m a huge fan of collaboration and sharing best practices (that’s one of the reasons why I write this blog!) so I like to hear other professional’s opinions and perspectives.  In addition to attending industry conferences, I do a lot of self-study, listening to podcasts, reading journals, and participating in webinars.  Most sessions are a…

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Clinical Site Budgets

Negotiating Clinical Trial Site Budgets for the Schedule of Assessments, one-time fees, and pass-throughs

[box style=”2″ close_btn=”true”] Money Matters: Today is payday, 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] Debits, and Credits, and Finance, oh my! Clinical Site Budgets Negotiating Clinical Site Budgets For today’s installment, let’s…

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What is a Clinical Operations Toolkit?

Combining ability, character, and training into a toolkit allows clinical research professionals to problem-solve on the fly

Combining ability, character, and training into a toolkit allows clinical research professionals to problem-solve on the fly and provide quality support for challenging and complex studies.  Administrative skills, interpersonal techniques, intellect, personality, and technical skills all improve with depth of experience.  A little humility helps, too.  As with any individual tool or group of gizmos,…

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