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
Applied Clinical Trials
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
Applied Clinical Trials
Electronic Health Record (EHR) systems are being used increasingly by clinical investigative sites.
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Latest Updated Articles
Can Data from EHR Systems Be Trusted in a Trial Setting?January 1st 2019
Keeping Up with the Regulatory ExpectationsJuly 8th 2019
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