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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Little Wrap Dress

One of my co-workers commented the other day that I really own a lot of dresses.  OK, that is true but it hasn’t stopped me from adding this little beauty to my birthday wishlist! My go-to garment in my work wardrobe is the wrap dress (recommended only for the ladies, sorry guys!).  The wrap dress is perfect…

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Perfect Clinical Trial Source Documents

Perfect clinops tooklit source

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 training, track investigative supplies, and to review source documents.  Clinical Trial Source documents are the roadmap and clinical record to let me (or anyone who is reviewing)…

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Fueling Up the Rental Car

Which side is the gas tank located on?  Here are two quick tips to help you find it super fast.  1) If there is a little pull switch inside the car, pop the gas tank door and listen for the sound to determine the correct side to pull up to the pump.   2) Even easier…Take…

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Happy New Year

2011 Happy New Year from The Lead CRA

Thank you for your continued readership of the Lead CRA blog and I wish everyone a happy and healthy 2011.  I hope that you will continue to follow along as I have made a resolution to keep posting and updating the blog with new content on a regular basis. This greeting comes a little late…

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What is up with this coordinator?

understanding your study 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 phone, email, or query requests.  Other times they are behind on their Screening/Enrollment logs, supply requests, data entry, etc.  As a CRA…

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Myths About Clinical Trial Site Selection

Nadia presents some “myths” about site selection at a dinner for the San Francisco ClinOps Toolkit meetup group.

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