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Pharmatimes US Clinical Researcher of The Year

Tell Them About the US Clinical Researcher of The Year Competition The US Clinical Researcher of the Year competition has been accepting nominations since March.  They will continue to accept nominations until September, but why wait?  Nominate someone today who works hard in Clinical Research and deserves to be recognized.  There are separate categories of awards…

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Are you at DIA? #DIA2013

This weekend, many clinical research folks headed to Boston for the 49th annual Drug Information Association conference.  Although I didn’t make it this year, I’d love to hear from you if you attended; especially if you are a Clinical Research Associate. Is the conference valuable for CRAs?  Would you like to share some highlights of…

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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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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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You are The Lead CRA: Five Years Later and a New Blog Format

Somehow I managed to completely miss my blog anniversary…by a long shot.  I’ve been the Lead CRA author for over five years and thanks to your collective 250,000+ visits the project has been a personal success and very rewarding.  In October of 2007 I started the blog as a place to catalog my adventures in…

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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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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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