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IMARC Blog

Compliance In Focus

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Posted by Brandy Chittester on Wed, Mar 04, 2015

“If it is not documented, it was not done”

Topics: 21 CFR 812.140, Documentation, FDA, Clinical Research

Posted by John Lehmann on Tue, Jul 10, 2018

Documentation in Device Studies: Proving Patient Protection

Topics: Documentation, Medical Device Studies, IMARC Research, Clinical Research

Posted by Kelly Schindelholz on Fri, Jun 03, 2016

“If it is Not Documented it Wasn’t Done.”

As monitors we sort of live by this motto and we always try to remind our sites of this, we do so in order to help protect the subjects, their site, and the Sponsor of the study all at the same time.

Topics: Documentation, FDA, Auditing, Clinical Monitoring

Posted by Brandy Chittester on Wed, Mar 04, 2015

Documentation of the Informed Consent Process – What is Required?

We have had this discussion numerous times over the years.  Many believe that the informed consent form is documentation enough.  On the other hand, others would like to see all consent processes documented with a progress note, in addition to the consent document.

Topics: Informed Consent Process, Documentation, Protection of Human Subjects

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