Summer Vacation

Lead CRA visit to Yunnan province Dali China

I hope everyone has exciting plans for the summer or at least a plan to beat the heat.  Temperatures in San Francisco were almost 75 degrees Fahrenheit this week.  I don’t have air conditioning and my home is in the upper level of a beautiful Edwardian building…at the top of four flights of stairs, this has been…

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Beauty Break

More CRA related posts soon but today I am off-topic and burning through some birthday giftcards and shopping online.  I am going to share some of my favorite beauty buys with you loyal readers, hope this will be of interest. This book just arrived in the mail for me today and I can’t wait to…

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Efficiency Tips: Keep the Inbox and Sent Box Empty….and Archive Emails Weekly

This is my Outlook folder list. I try to  keep the inbox at less than 20 items at  all times. Today is Wednesday. I have received/sent and processed over 300 emails. Other Clinical Operations people in my immediate working group see even more traffic in their inbox but I can conservatively say that around 120 emails…

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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 data worksheets/templates arguing that source data should not contain instructions nor any other items (logo, etc.) which would not usually appear on a patient medical file.  Is there…

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On the Road Again

Remarkably, I’ve only taken three work trips so far this year.  Luckily, I have been doing transcons so my mileage balances and quest for elite status aren’t suffering too terribly (12 segments and 17,000 qualifying miles in 2011).  That said, I haven’t had a lot of travel stuff to report lately but here is a…

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Efficiency Tips: Tackle the Correspondence Tab

Group and Organize the Paper Monster That behemoth regulatory binder binder could definitely be less daunting. Section it out logically by slipping a colored piece of paper or a tab in to demarcate each quarter. Replace the binder A new binder is less than $5. If the rings are damaged and every time you flip…

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Every Email is an Essential Document…or perhaps not

every email is an essential document

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 generate end up in the correspondence tab. This is because I do a lot of back-and-forth…

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Site Master File: Correspondence

clinical trial site master file secure

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 allows sponsors, auditors, regulators, and all other interested parties to reflect back on a clinical trial and understand how things were conducted,…

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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 reporting, screening/enrollment logs, issue identification, etc. We have them prepare the CRFs, complete data-entry, attend trainings, review newsletters/correspondence/memos, answer emails, fax…

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Monitoring Wardrobe

TNM said…   Hi Nadia,   Thank you for the suggestions. What kind of shoes would you suggest when wearing wrap dresses on site visits? Any examples of cute and professional shoes in general? Would love to see a more extensive monitoring wardrobe. Again, thank you. FEBRUARY 18, 2011 11:20 AM  Hi TNM, I was worried…

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