Site System Assessments - eClinical Forum the esource-readiness assessment tool (esra) The tool contains questions based on regulations and regulatory agency guidelines for clinical research data sources and should be used to evaluate the suitability of an Investigator Site computerized system to provide data for clinical trials
Site System Assessments - eClinical Forum eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: ENGLISH Version 2024 This is the ONE FILE that you need to perform an eSRA Assessment This 2024 version has updates based on the EMA Guideline on computerised systems and electronic data in clinical trials
Site Sys Assmts - eClinical Forum eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: ENGLISH Version 2024 This is the ONE FILE that you need to perform an eSRA Assessment This 2024 version has updates based on the EMA Guideline on computerised systems and electronic data in clinical trials
eSRA Handbook and Assessment Forms V2025 - eclinicalforum. org Sites should complete an e-Investigator File System Assessment (Form F) for any site system that will be used to store manage documents pertaining to the clinical trial - Download the Handbook file and save to your computer The instructions for completing the eSRA forms are in section 3, and the assessment forms are in section 7
Japanese translation of eSRA V2024 - eClinical Forum The eSRA Questionnaire Version 2024 can be downloaded as part of the eSRA Handbook below (This version incorporates changes based on the EMA Guideline on computerised systems and electronic data in clinical trials )
eSRA V2024 (eSource-Readiness Assessment) Handbook and Questionnaire eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire: ENGLISH Version 2024 This is the ONE FILE that you need to perform an eSRA Assessment This 2024 version has updates based on the EMA Guideline on computerised systems and electronic data in clinical trials
Site Sys Assmts - eClinical Forum The eClinical Forum offers 2 absolutely free system assessment forms that consist of regulatory-based questions for evaluating the suitability of an investigator site system to provide data records for clinical trials Both forms are part of the eSRA Handbook which provides guidance to sites on how to complete the forms We request that Sponsors
Site Sys Assmts This document provides an easy look at the differences between the 2 eSRA Forms (Form S for eSource and Form F for eFile systems) as well as a comparison to the previous versions of each as well as a mapping to the underlying regulatory statements that support each eSRA question
eSRA - eClinical Forum The 2025 version is now available in the eSRA Handbook and Assessment Forms V2025 This version will be removed on June 30, 2025
Site Sys Assmts The eClinical Forum offers 2 absolutely free system assessment forms that consist of regulatory-based questions for evaluating the suitability of an investigator site system to provide data records for clinical trials Both forms are part of the eSRA Handbook which provides guidance to sites on how to complete the forms We request that Sponsors