Prominent Industry Magazines address the need for investigator site systems assessment and eSRA
Applied Clinical Trials (English, December 2018) - English
PHARMSTAGE (Japanese, October 2019) - 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.