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Ensures electronic source data meets GCP (Good Clinical Practice) and regulatory requirements.
Covers data integrity, security, audit trails, and user management of site systems.
It is intended for computerized systems that originate data, not for simply scanning paper documents into a repository. How to Use eSRA
on how a site should fill out the assessment?
It is a standardized, free-of-charge tool used globally by clinical research sites to self-assess their computerized systems (EHR/EMR) to ensure compliance with regulatory guidelines (such as EMA and ICH E6(R3)). Core Components of eSRA
eSRA Handbook and Assessment Forms V2025.3 - Site Sys Assmts
Ensures electronic source data meets GCP (Good Clinical Practice) and regulatory requirements.
Covers data integrity, security, audit trails, and user management of site systems.
It is intended for computerized systems that originate data, not for simply scanning paper documents into a repository. How to Use eSRA
on how a site should fill out the assessment?
It is a standardized, free-of-charge tool used globally by clinical research sites to self-assess their computerized systems (EHR/EMR) to ensure compliance with regulatory guidelines (such as EMA and ICH E6(R3)). Core Components of eSRA
eSRA Handbook and Assessment Forms V2025.3 - Site Sys Assmts
