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Compliance In Focus
Posted by Kelly Schindelholz on Mon, Nov 25, 2013

Essential Documents - What Will Regulatory Binders Look Like in 5 Years?

Binders, huge files, and tons of paper….this is what researchers have become accustomed to. What Will Regulatory Binders Look Like  in 5 Years Some Sponsors have allowed sites to house certain items electronically, most often communication either emails between the site and Sponsor or IRB communication.  But more often than not Sponsors require these items to be printed and housed in files or binders.

Research coordinators often talk about how space is such a premium and how difficult it has become to house all these documents.  They often jokingly ask “when will regulatory binder be electronic?”  It is true, and not only for the sites, but for the Sponsors as well, they also have mounds of binders full of documents to store. 

21. CFR 812.140 describes the responsibilities for maintaining records for medical device studies.   The regulation describes that records must be maintained, and that they are accurate, complete, and current. It goes on to describe what types of records are to be included, but it doesn’t specify these records must be printed records, only that the records must be maintained.    

What is your take, are electronic regulatory binders the way of the future?

Photo Credit: gcoldironjr2003

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Topics: Research Coordinators, Regulatory Binder, Sponsors


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