A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
Suzanne Bishop
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Articles by Suzanne Bishop
An increase in use of EHR systems at clinical investigative sites adds more expectations for clinical trial sponsors to comply by regulatory requirements.
Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting
Electronic Health Record (EHR) systems are being used increasingly by clinical investigative sites.
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