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.rar
Used to assess electronic systems that store or manage documents related to the clinical trial. Key Features and Purpose on how a site should fill out the assessment
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 Key Features and Purpose Sites may separate the
For detailed information, updates, or to send feedback, the eClinical Forum can be reached at esra@eclinicalforum.org. between the 2024 and 2025 versions?
The completed forms are sent to sponsors/CROs as evidence of system readiness.
It is intended for computerized systems that originate data, not for simply scanning paper documents into a repository. How to Use eSRA