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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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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Monitoring Tools & Notes

monitoring tools to save you time

Monitoring Tools and Notes As a regional monitor, I have primarily worked on studies with a conduct period of only a few months.  For these trials, I can typically monitor an entire subject’s source in just a couple of monitoring visits (IMVs).  However, I do use a few monitoring tools to keep me organized and…

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3 Simple Ways to Improve the Approach

improve the approach in clinical trial services

I was invited to speak on a panel this week at the Outsourcing in Clinical Trials West Coast conference.  This was my second year in attendance and the conference was an excellent investment of my time with lots of great networking and informative sessions.  The topic for my panel was “Examining mistakes some vendors make…

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Striving for Improved Investigator and Site Relationships

Last year I was invited to present at a conference in San Francisco; it was a wonderful experience. Here are this year’s conference details. 5th annual Outsourcing in Clinical Trials West Coast I was just organizing some files on my computer and came across the slidedeck, “Striving for improved Investigator and site relationships to achieve…

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Tips for Better Monitoring Visits

These are four tips for great monitoring visits.  It all comes back to developing solid relationships as a site manager so you will have access, cooperation, and enjoy more productivity during your time on site. 1. Effective Communication Between Visits Maybe your coordinators truly are time-strapped or maybe they just need a little cheerleading.  Great…

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Obtaining Consent More Efficiently

Obtaining Consent for a Clinical Trial Anonymous asks about obtaining consent…  Feb 19, 2012 12:55 PM Hi Nadia, I am very grateful for such an amazing site. I am regularly reviewing your site to know more about CRA responsibilities. I have one question regarding the patient consent form, as per GCP can the patient sign the…

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Lead CRA Q&A: Do We Have To Do an SIV?

Melissa commented in… “Pre-Study Visits and Site Initiation Visits“: Do sites HAVE to have an SIV? Especially for a simple data collection study? Or is a web training sufficient for sites that have done research with us before?  –September 9, 2011 The Lead CRA responds… Hi Melissa, it sounds like you may be working on a non-interventional…

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Lead CRA Q&A: Meeting with a Principal Investigator

my PI thinks they are too important to meet with my CRA

Anonymous commented in…“Routine Monitoring Visits“: Could you please give advice about how to deal with the “difficult” Principal Investigator who doesn’t want to meet you despite the numerous efforts to persuade him? Any recommendation would be very appreciated! –May 26, 2011 2:54 PM The Lead CRA responds… Thank you for a great question.  I’ve partially…

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5 Career Tips for a Young CRA

Nurture and grow your career

I came across a fun little article on biospace that offers career advice: 5 ways to be a rockstar at work (via Biospace). This post echoes the format of that article and I hope you will find it interesting and leave me a comment or email some feedback. Although I have transitioned to in-house, the…

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