Allows a site to perform one assessment and share it with multiple sponsors, reducing workload.

Based on your request, the most relevant, detailed content regarding "eSRA" (often referenced in contexts like "eSRA.rar" for downloading packages) refers to the developed by the eClinical Forum .

eSRA Handbook and Assessment Forms V2025.3 - Site Sys Assmts

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

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:

Covers data integrity, security, audit trails, and user management of site systems.

The site IT and research staff complete the questionnaire, identifying any risks and necessary actions.

The completed forms are sent to sponsors/CROs as evidence of system readiness.