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Posted by Stephani Hulec on Fri, Jun 03, 2016

What to do when your site no longer “cares” about a study you are monitoring?

It is usually not very difficult to engage sites who have been chosen to participate in a clinical study at the beginning of the trial.  This is an exciting time for any site that is able to bring that new experimental drug or device to their patients who are able to participate in the study!  Many times, during the enrollment phase of the study, sites continue to be excited and active in their roles, and this is usually facilitated by sponsors who are actively encouraging their sites to enroll subjects.

Topics: Clinical Study, Site, Regulations, Clinical Monitoring

Posted by John Lehmann on Wed, Mar 04, 2015

Is a Delegation Log Required?

As monitors, we come across this question from time to time…Is a Delegation log required?

Topics: Clinical Study, 21 CFR 312 and 812, Delegation Log, FDA

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Clinical Research Training Requirements
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