Allows a site to perform one assessment and share it with multiple sponsors, reducing workload.
eSRA Handbook and Assessment Forms V2025.3 - Site Sys Assmts Esra.rar
Sites may separate the forms from the handbook after completion such that they are only sharing and storing the completed forms. * eClinical Forum Site System Assessments - eClinical Forum Allows a site to perform one assessment and
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 Core Components of eSRA Used to assess systems
Used to assess systems that originate or manage data destined for clinical research, such as Electronic Health Records (EHR).
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: