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Compliance In Focus
Posted by Kelly Schindelholz on Tue, Nov 26, 2013

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

If it is not documented it wasn’t doneAs 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.

At any given site across the country the work probably includes multiple Sponsors and many different studies.  With so much going on how do we remember things from a week ago, a month ago, a year ago?  What if you won the lottery tomorrow, would your replacement be able to tell the story of those subjects, those studies at your site?  Documentation is crucial in research and sometimes we overlook conversations we should be documenting.

Here is an example: while monitoring at a site the monitor noted an informed consent that had not been dated by the subject, it appears to have been dated by someone else.  The monitor discusses this with the site and recommends informing the IRB.  The research coordinator calls the IRB and the person on the other end informs them it is not reportable.  Do you think the research coordinator would remember that conversation, when it happened, who she talked to in a year during an FDA audit when the issue is again highlighted?  I’m not sure, maybe, but probably some of those details would be a little fussy.  So in this example the monitor suggested documenting every detail of the conversation, the date, time, the name of the person she spoke with, and the referenced policy in which determined this event was not reportable.

Documentation is especially important during phone calls however it can be important during other instances as well.  Always think about if you won the lottery and are no longer at your site, would someone else be able to find the answer to a subject’s question, a monitor’s question, an auditor’s question?

What is your documentation process at your site?

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Topics: Documentation, FDA, Auditing, Clinical Monitoring


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