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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ACRP 2012 Global Conference in Houston, TX

Association of Clinical Research Professionals - ACRP

I received a mailer the other day with program details for the ACRP 2012 Global Conference.  I am on the ACRP mailing list but I have never attended the conference before.  This year it is being held in TX April 14-17.  There are a handful of sessions I would be interested in and I think…

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Lead CRA Q&A: Consenting Subjects Before IMP is On-site

properly consent subjects before dispensing investigational new drug

Are we ready for Consenting Subjects? Anonymous commented in… “Pre-Study Visits and Site Initiation Visits“: November 26, 2010 Post SIV, can a site share the Informed Consent Form (ICF) with pre-identified subjects prior to Investigational Medicinal Product (IMP) receipt at the site? The Lead CRA responds on consenting subjects… Hi and thanks for your question. In…

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The Memo to File or Note to File (NTF) is Overused

How Important is that Note to File

A Note to File is not always the best way to capture Information These memos are often sloppy, contradictory, confusing, or alarming (I once monitored at a site where the PI had written the following memo “Although employees and family members of Dr. XXXX and this facility were enrolled in the trial XXXX, they were…

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Today in History (and The Lead CRA blog traffic statistics)

On October 12th: 1792 – the first celebration of Columbus Day commemorated the 300th anniversary of Columbus’ landing in the Caribbean in 1492. 12-Oct-1999: A teacup yorkshire terrier named George (the author’s favorite artist from the band The Beatles) is born. 1850 – The 1st women’s medical school, the Women’s Medical College of Pennsylvania, opens. 1928 – An iron lung respirator is used…

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ACRP The Monitor Magazine

The Association of Clinical Research Professionals (ACRP) has a very active chapter in San Francisco, California.  When I first moved to California and wanted to become a CRA, the local chapter assisted me with some helpful connections and networking opportunities.  I learned about a clinical research certificate program through a local university, attended seminars on clinical research topics…

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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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