ICON Warning Letter from the FDA
Please check out a recent warning letter sent to ICON Clinical Research in regards to monitoring services they provided for two antibiotic trials. Routine Inspections Triggered Serious Findings My...
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New Year, New Destinations, New Perks?
I’m out on my first work trip of the year performing a few Site Initiation Visits for a new drug study in Southern California. I’ve definitely logged some serious miles flying SFO->LAX in my time...
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Selecting Qualified Investigators
The focus of this post will be selecting adequately performing US clinical trial sites for Investigational New Drug studies. Depending on the nature and size of your clinical trial, you may be...
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Investigational Product Accountability
Clinical trials are conducted for new investigational products and also to explore additional endpoints/indications for marketed products or combinations. The medication dispensed in the clinical...
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What is up with this coordinator?
How can we motivate? In a separate post I provide you tips and advice for motivating and working well with your coordinators. However, sometimes it is hard to get a Study Coordinator to answer the...
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Perfect Clinical Trial Source Documents
As a CRA, I regularly visit the sites to review the study conduct, encourage study participant recruitment, evaluate the ongoing suitability of the investigative site, provide protocol specific...
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Motivating your Study Coordinators
As monitors, we rely on the Study Coordinators (SC) to assist us in site management activities like record-keeping and re-supply. We ask them to keep us informed of progress at the study site through...
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Site Master File: Correspondence
The Site Master File (SMF) or Regulatory Binder contains all of the essential documents to provide a record of study conduct. The SMF when reviewed with the clinical charts and archived study materials...
View ArticleEvery Email is an Essential Document…or perhaps not
Wait, you said I shouldn’t file every email? Please, no, for the love of all that is Holy, don’t file every email. I currently manage 15 sites and as a general rule, only about 1 in 10 emails I...
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Lead CRA Q&A: Sponsor Furnished Source Documents
Source Documents in clinical trials Anonymous commented in… “Perfect Clinical Trial Source Documents“: Hi, some sponsors don’t allow investigators to use source documents in clinical trials such as...
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5 Career Tips for a Young CRA
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...
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Lead CRA Q&A: Meeting with a Principal Investigator
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...
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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...
View ArticleObtaining 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...
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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...
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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...
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3 Simple Ways to Improve the Approach
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...
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Monitoring Tools & Notes
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...
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Financial Disclosure Forms
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...
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Monitoring Visit Follow-Up Letters
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...
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