It is intended for computerized systems that originate data, not for simply scanning paper documents into a repository. How to Use eSRA
The site IT and research staff complete the questionnaire, identifying any risks and necessary actions. Esra.rar
Ensures electronic source data meets GCP (Good Clinical Practice) and regulatory requirements. It is intended for computerized systems that originate
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 Sites may separate the forms from the handbook
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:
Used to assess systems that originate or manage data destined for clinical research, such as Electronic Health Records (EHR).