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Compliance In Focus
Posted by John Lehmann on Mon, Jan 16, 2012

Documentation in Device Studies: Proving Patient Protection

Please take time to download IMARC's most recent white paper, written by Brandy Smith, Chief Clinical Officer 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 and let us know what you think.

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

Topics: brandy smith, FDA, Clinical Research

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