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Posted by Stephani Hulec on Wed, Jun 17, 2015

Essential Document Review, What are you Looking For?

As monitors we spend a significant amount of time reviewing the essential documents at the site during a monitoring visit.  The essential documents are usually housed in a Regulatory Binder or sometimes they are referred to as an Investigator Binder.

Topics: Monitor, Regulatory Binder, Essential Documents, Sites

Posted by Sandra Maddock on Wed, Mar 04, 2015

Essential Document Review, What are You Looking For?

As monitors we spend a significant amount of time reviewing the essential clinical investigation documents at the site during a monitoring visit.  These ‘essential documents’ are usually housed in a Regulatory Binder or sometimes they are referred to as an Investigator File.

Topics: Essential Documents, Monitoring Visit, IRB

Posted by Jacqui Lingler on Wed, Mar 04, 2015

Signatures in Essential Documents – What is Required?

As monitors we spend a significant amount of time reviewing the Investigator File and the essential documents filed with in it at a site visit.  There are many things we look for; here are just a few:

Topics: Wet Ink Version, Investigator File, Essential Documents

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Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.