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Posted by Kelly Schindelholz on Wed, Mar 04, 2015

What Do I Do When Source is Incorrect?

In general, most hospitals and clinics use electronic medical records (EMR), or a mix of electronic and paper medical records.  Often paper records are scanned into the EMR in order to house all records for a particular patient in one location.

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Topics: ISO 14155, Electronic Medical Records, Source Documentation, Clinical Monitoring

Posted by Brandy Chittester on Wed, Mar 04, 2015

Is a Worksheet Adequate as Source Documentation?

In a perfect world, all the data needed to complete a clinical trial case report form would be found in the medical record. Unfortunately, we do not live in a perfect world!

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Topics: ICH GCP, FDA Warning Letters, Worksheet, Source Documentation

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