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.

Clinical research draws on a combination of data collected during a clinical trial and historical medical information relating to the research subject(s). Many of the data points needed for clinical research are originating in Electronic Health Record Systems, making them "eSource" for clinical research. Even if these data points are not used directly from the site's healthcare system, but are re-entered into a Sponsor's system for a clinical trial, the source of the information (the healthcare system) must still be confirmed as compliant with standards set forth in clinical research regulations and applicable guidance documents.

An eClinical Forum team, comprised of CRAs and Data Managers from different clinical research sponsor organizations and CROs and representatives from sites, has produced the "eSource-Readiness Assessment", otherwise known as "eSRA" for sites to perform a self-assessment of their computerized system's ability to be compliant with clinical research regulations.

The eSRA Questionnaire Version 2022 can be downloaded as part of the eSRA Handbook below.

Stay Current!!

As new regulations are released or updated, the eClinical Forum will evaluate if the eSRA questions should be updated. To be notified of future releases of the eSRA Questionnaire, please send an email to eSRA@eClinicalForum.org. Your email address will not be used for purposes other than to inform you of updates to eSRA.

Sponsors & CROS -- Please take our very brief survey regarding how you are using eSRA.  This will help us improve eSRA. Survey link: eCF eSRA Survey (eclinicalforum.org) THANK YOU!!!

Do we keep a list of sites that have completed eSRAs?

We have frequently been asked if we can provide a list of which sites have already completed an eSRA. Due to privacy laws in different countries, eClinical Forum does not keep such a list. We supply the eSRA questionnaire, free of charge, to anyone who wants to use it. We encourage sponsors to keep a list for themselves of which sites they have received a completed eSRA from. We encourage sites to store their completed eSRA in a central location (such as their IT department) so that other groups within the same organization / using the same electronic healthcare system, can use the completed eSRA as a basis to complete their own eSRA.

eSRA RESOURCES – Scroll to see all resources

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021

5 May 2021 0
3175
eSRA Slides suitable to present to your organization

eSRA Slides suitable to present to your organization

15 July 2019 0
4881
Is your electronic health record system suitable for originating records that will be used in regulated clinical trials?

Is your electronic health record system suitable for originating records that will be used in regulated clinical trials?

Nearly 200 attendees participated in a webinar delivered by the eClinical Forum for ACRP.

The objective of the webinar was to allow attendees to:

  • Recognize the need to assess their electronic healthcare system to determine its appropriateness for originating and/or housing data that could be used in a regulated clinical research trial
  • Access a free tool to assist in assessing electronic health record systems
2 March 2016 0
1740
Site Survey Presentation - DIA Clinical Forum Lisbon 13 Oct10

Site Survey Presentation - DIA Clinical Forum Lisbon 13 Oct10

Revisiting the eClinical Paradigm

Investigational Site Perspectives on Clinical Trial Information Systems

 

As the healthcare and pharmaceutical technology spheres move closer together at the clinical research interface, the eClinical paradigm needs to be revisited in order to leverage emerging political, cultural, procedural and technological opportunities. Understanding investigational site experiences with today’s clinical trial technologies and their perspectives on future requirements is critical to delivery of improved eClinical solutions.

3 December 2015 0
1716
EHR4CR: An Innovative Platform and Business Model for Re-Use of EHR for Clinical Research (ACDM UK 10Mar14)

EHR4CR: An Innovative Platform and Business Model for Re-Use of EHR for Clinical Research (ACDM UK 10Mar14)

Improved access to patient data is key to managing bottlenecks in clinical research. The presentation gives an overview of one of the largest public-private partnerships aimed at providing adaptable, reusable and scalable solutions for re-using patient level data from Electronic Health Record systems for Clinical Research.

3 December 2015 0
1796
eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data for Clinical Trials (ACDM UK 10Mar14)

eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data for Clinical Trials (ACDM UK 10Mar14)

Investigators are frequently asked to complete sponsor-specific assessments of their EHR systems to enable sponsors to evaluate clinical trial data that will be sourced from these systems.

3 December 2015 0
1748
Investigator Site eSource-Readiness Assessment Tool

Investigator Site eSource-Readiness Assessment Tool

The eClinical Forum eSource Sub-team is working on a common assessment tool to determine Investigator Site eSource-Readiness.

9 August 2013 0
1485
EHR4CR - A new technological platform enabling the re-use of data from electronic health records

EHR4CR - A new technological platform enabling the re-use of data from electronic health records

CASE STUDY EHR4CR - A new technological platform enabling the re-use of data from electronic health records.

12 March 2013 0
1297