Esra.rar

Used to assess electronic systems that store or manage documents related to the clinical trial. Key Features and Purpose

Ensures electronic source data meets GCP (Good Clinical Practice) and regulatory requirements. Esra.rar

Allows a site to perform one assessment and share it with multiple sponsors, reducing workload. Used to assess electronic systems that store or

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

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

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: