Prominent Industry Magazines address the need for investigator site systems assessment and eSRA
Applied Clinical Trials (English), PHARMSTAGE (Japanese)
Electronic Health Record (EHR) systems are being used increasingly by clinical investigative sites; and there is a growing expectation, by regulatory agencies, for clinical trial sponsors to verify that EHR systems comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment. eClinical Forum provides a free tool to assist sponsors and sites in deternining if their EHR systems are appropriate to source clinical research data.
This very important topic has been featured in 2 prominent industry magazines:
Applied Clinical Trials (English, December 2018) has published an article on the eCF eSource-Readiness Assessment (eSRA). eSRA is a list of questions, based on regulation and guidance from FDA, EMA, PMDA, and ICH for Clinical Research sites to self-assess their readiness to provide data from their electronic health records systems. This data may be electronically supplied to sponsors, or manually entered into a sponsor system, however if it originates in a healthcare system, then sponsors are responsible for assessing that these systems are appropriate.
For complete article, please see Applied Clinical Trial website: http://www.appliedclinicaltrialsonline.com/determining-if-data-electronic-health-record-systems-can-be-trusted-clinical-trial-setting
PHARMSTAGE (Japanese, October 2019) has published an article titled “Assessment of Reliability of Electronic Health Records Data Used in Clinical Trials”. It is a six-page article to discuss global regulations on EHR data, describe what eSRA is and how it is used.