For detailed information, updates, or to send feedback, the eClinical Forum can be reached at esra@eclinicalforum.org. between the 2024 and 2025 versions?
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
Download the latest eSRA Handbook and Assessment Forms . Esra.rar
Ensures electronic source data meets GCP (Good Clinical Practice) and regulatory requirements.
It is intended for computerized systems that originate data, not for simply scanning paper documents into a repository. How to Use eSRA For detailed information, updates, or to send feedback,
The completed forms are sent to sponsors/CROs as evidence of system readiness.
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 * eClinical Forum Site System Assessments - eClinical
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: