Efficiency Tips: Spend less time on your Timesheet

I am employed by a service company and we bill our clients for our services. Therefore, we must track our time spent on sponsor related work and pass the costs through appropriately. I am asked to track my time in 15 minute increments so I can basically report up to 4 time categories per hour…

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Efficiency Tips: Spend less time on Monitoring Visit Reports

Many Protocol and Many Monitoring Visit Reports Draft Monitoring Visit Reports before you even arrive on site As a monitor, you may visit several different study sites in a single week and possibly for different protocols. I often find when I get home from a trip like that it is hard to write my report…

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Efficiency Tips: General and Administrative Duties

I work at a CRO so we have a fairly robust on-line expense reporting system and a thorough web-based system for reporting our billable and non-billable time through an interactive on-line timesheet. Well, I don’t have the new iPhone and we still can’t access the internet while in-flight so I am not exactly on-line all…

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Less schwag? How much less?

Just checked out a news article from The Pharmaceutical Research and Manufacturers of America (PhRMA) about the revised marketing code: http://www.phrma.org/sites/default/files/pdf/phrma_marketing_code_2008.pdf It seems that new regulations (regulations to which drug manufacturers may or may not voluntarily adhere) will limit the goodies that sales reps can give to MDs in their sales calls. Reps can still…

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Close-Out Visits

closeout and archive files

I’ve done about 10 close-out visits in the last few months so it feels like a good time to write a short article explaining what the objectives of these visits are and how a typical close-out visit (COV) is conducted. Clinical Trial Site Close-Out Visit A close-out visit will occur once subjects are no longer…

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Who’s running this study?

I just received an interesting article from a colleague: http://www.tampabay.com/news/business/article463686.ece Was the Principal Investigator Providing adequate oversight? The article discusses a clinical research unit in Florida where the PI oversight isn’t exactly verifiable. This is always an issue for us as monitors, especially when the Dr. practices from one location and the study is conducted…

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Routine Monitoring Visits

Routine monitroing visits clinops toolkit

Routine or Interim Monitoring visits are basically any visit that occurs after the site is initiated and up until the site is closed out. As monitors, we visit our sites periodically to ensure that they are compliant with all the regulations, subject safety is being adequately followed, data is being captured in a timely and…

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Clinical Fraud Hearing Held Today

I received an email from my old boss today alerting me to an interesting webinar. I am posting it for other people’s benefit. She states “The webcast below is a hearing to explore fraud at a clinical site for a study conducted by Sanofi-Aventis. The hearing took place this morning. Interestingly, the CRO and the…

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What to Expect at a CRA Interview

What to Expect at a CRA Interview_feature

I’m posting to let you know what kinds of questions you might expect to be asked during a CRA interview. Practice these in the shower, in front of the mirror, or with a friend so you are prepared! Typical Questions Here are general questions that you will likely be asked with tips for answering shown…

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Home from the Investigator’s Meeting

I’ve been assigned another study and attended a kickoff and Investigator Meeting on the East Coast last week. As I mentioned in my last post, an Investigator’s Meeting is basically a chance to get all the doctors and staff together at one venue with the sponsor (usually a fancy hotel or somewhere fun) so that…

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