Ensures electronic source data meets GCP (Good Clinical Practice) and regulatory requirements.
The eSRA package (typically downloaded as a .zip or .rar file) contains a handbook and assessment forms, which as of April 2025 are in version V2025.3. It consists of two main forms:
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
on how a site should fill out the assessment?
For detailed information, updates, or to send feedback, the eClinical Forum can be reached at esra@eclinicalforum.org. between the 2024 and 2025 versions?
eSRA Handbook and Assessment Forms V2025.3 - Site Sys Assmts