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Compliance In Focus
Posted by John Lehmann on Mon, Feb 17, 2014

Documentation in Device Studies: Proving Patient Protection

Please take time to download IMARC Research’s whitepaper, written by Brandy Chittester, Documentation in Device StudiesDirector of Clinical Monitoring Services  for IMARC.  In summary, regulations that govern clinical research were put in place to protect clinical research subjects, and during FDA inspection, the extent to which a clinical researcher complied with those regulations – or protected patients – will come under scrutiny. If in doubt about the appropriate documentation practices, read though the regulations in question and think to yourself, how can I document my compliance with the regulation?   

Oftentimes we make decisions in order to meet the regulations, but neglect to take that extra step to document our actions. If someone was to review your work, would it be clear that the regulations were followed?  The patients protected?  Please take time to review the whitepaper and let us know what you think.

After all, “if it’s not documented, it’s not done!”

Photo Credit: qisur

Documentation in Devices

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


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