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  • Brussels 15-17 May 2019
    Brussels 15-17 May 2019
  • Danbury 8-10 April 2019
    Danbury 8-10 April 2019
  • Tokyo 5-6 November 2018
    Tokyo 5-6 November 2018
  • Paris, France 23-25 October 2018
    Paris, France 23-25 October 2018
  • Philadelphia, USA 2-4 October 2018
    Philadelphia, USA 2-4 October 2018
  • Princeton 1-3 May 2018
    Princeton 1-3 May 2018
  • Darmstadt, 15-17 May 2018
    Darmstadt, 15-17 May 2018
  • Tokyo 4-5 December 2017
    Tokyo 4-5 December 2017
  • Wellesely, MA 16-18 October 2017
    Wellesely, MA 16-18 October 2017
  • BERLIN 26-28 SEP 2017
    BERLIN 26-28 SEP 2017
  • REYKJAVIK 8-10 MAY 2017
    REYKJAVIK 8-10 MAY 2017
  • BLUE BELL, PA 24-26 OCT 2016
    BLUE BELL, PA 24-26 OCT 2016
  • BASEL 10-12 OCT 2016
    BASEL 10-12 OCT 2016
  • SINGAPORE 1-3 JUNE 2016
    SINGAPORE 1-3 JUNE 2016
  • UPPSALA 17-19 MAY 2016
    UPPSALA 17-19 MAY 2016
  • INDIANAPOLIS 25-27 APR 2016
    INDIANAPOLIS 25-27 APR 2016
  • NEW YORK 19-21 OCT 2015
    NEW YORK 19-21 OCT 2015
  • HORSHAM 5-7 OCT 2015
    HORSHAM 5-7 OCT 2015
  • SINGAPORE 3-4 SEP 2015
    SINGAPORE 3-4 SEP 2015
  • NORTH WALES, PA 18-20 MAY 2015
    NORTH WALES, PA 18-20 MAY 2015
  • SIENA 28-30 APR 2015
    SIENA 28-30 APR 2015
  • BANGALORE 5-6 FEB 2015
    BANGALORE 5-6 FEB 2015
  • CAMBRIDGE, MA 22-24 OCT 2014
    CAMBRIDGE, MA 22-24 OCT 2014
  • COPENHAGEN 16-18 SEP 2014
    COPENHAGEN 16-18 SEP 2014
  • SINGAPORE 20-21 MAY 2014
    SINGAPORE 20-21 MAY 2014
  • AMSTERDAM 14-16 MAY 2014
    AMSTERDAM 14-16 MAY 2014
  • BOULDER 30 APR - 2 MAY 2014
    BOULDER 30 APR - 2 MAY 2014
  • RESTON, VA 28-30 OCT 2013
    RESTON, VA 28-30 OCT 2013
  • DUBLIN 18-20 SEP 2013
    DUBLIN 18-20 SEP 2013
  • KASNSAS CITY 7-9 MAY 2013
    KASNSAS CITY 7-9 MAY 2013
  • EDINBURGH 22-24 APR 2013
    EDINBURGH 22-24 APR 2013
  • MONTVILLE, NJ 14-16 NOV 2012
    MONTVILLE, NJ 14-16 NOV 2012
  • MADRID 1-3 OCT 2012
    MADRID 1-3 OCT 2012
  • PARIS 21-23 MAY 2012
    PARIS 21-23 MAY 2012
  • EAST HANOVER, NJ 7-8 MAY 2012
    EAST HANOVER, NJ 7-8 MAY 2012
  • STRASBOURG 28-30 NOV 2011
    STRASBOURG 28-30 NOV 2011
  • NEWPORT BEACH 2-3 NOV 2011
    NEWPORT BEACH 2-3 NOV 2011
  • BANBURY 4-6 MAY 2011
    BANBURY 4-6 MAY 2011
  • CAMBRIDGE, MA 12-13 APRIL 2011
    CAMBRIDGE, MA 12-13 APRIL 2011
  • FORT LAUDERDALE 3-5 NOV 2010
    FORT LAUDERDALE 3-5 NOV 2010
  • BRUSSELS 6-8 OCT 2010
    BRUSSELS 6-8 OCT 2010
  • PARIS 5-7 MAY 2010
    PARIS 5-7 MAY 2010

WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.


News from the eCF

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eSRA

eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data

 

It is important that electronic health record systems (EHRS) that will supply source data for clinical research be designed and maintained to meet regulatory requirements. The eSRA project is developing a free tool that vendors and sites can use to quickly and easily evaluate their systems once for all sponsors, CROs, and regulators.

 

We are working on updating eSRA right now!
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We are working on updating eSRA right now!

Please provide feedback for Version 2019

Sponsors & CROs -- Please take a few minutes to complete this brief survey regarding how your company reviews site healthcare systems. We would like the input of every company whether you are using eSRA or your own assessment or not assessing at all.

https://www.surveymonkey.com/r/Site_System_Assessment_Survey

The link/survey will only be active until the end of May 2019, but we encourage you to complete the survey before Friday, February 22 2019, as we need the information to improve the eSRA Version 2019 which will be available the first week of March. Responses after Feb 22, 2019 will be considered for the 2020 version.

Sites -- If you would like to provide feedback for the eSRA V2019, please describe your feedback in an email to esra@eclinicalforum.org 

Thank you in advance for your help!

eClinical Forum eSRA Team (comprised of members from Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, OmniComm, Pfizer)

Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting
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Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting

Applied Clinical Trial's article on eCFs eSource-Readiness Assessment (eSRA)

Applied Clinical Trials has published an article on the eCF eSource-Readiness Assessment (eSRA). eSRA is a list of questions, based on regulation and guidance from FDA, EMA, PMDA, and ICH for Clinical Research sites to self-assess their readiness to provide data from their electronic health records systems. This data may be electronically supplied to sponsors, or manually entered into a sponsor system, however if it originates in a healthcare system, then sponsors are responsible for assessing that these systems are appropriate.

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2018.1
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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2018.1

Investigator Site self-assessment of their healthcare systems against clinical research regulations and guidance

We are proud to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. It is provided free on this website via the "eSRA" tab. This Version 2018.1 is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.

eSRA (eSource Readiness Assessment) Handbook and Assessment Template
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eSRA (eSource Readiness Assessment) Handbook and Assessment Template

Version 2018.1

This is the ONE FILE that you need to perform an eSRA EMR/EHR Assessment.

- Sites should complete an eSource-Readiness Assessment (eSRA) to self-assess their healthcare computerized systems (EHR/EMR) for readiness to originate or handle electronic data that could become part of a clinical research study.

- Sponsors/CROs will find useful information in the Handbook in order to evaluate a completed eSRA from a site, to determine if data that originated in the site's healthcare computerized system complies with clinical research regulations

- Download the Handbook file and save to your computer. The instructions are in section 3 and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors.

eSRA V2019 is coming (end of Feb 2019) -- we are looking for CR Sites or eCF Member Sponsors & CROs to join the eSRA team in reviewing changes for the 2019 version! Please contact eSRA@eclinicalforum.org if you are interested.

Click on title to get to the download screen.

Investigator Site Survey .. Please Participate
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Investigator Site Survey .. Please Participate

Partnering for Success

The ongoing Investigator Site Survey survey is open to all site staff involved in clinical trials. By participating in this survey, you will help us to better understand the experience and needs of site staff with clinical trial systems and processes. This is not eSRA -- it is a voluntary survey -- it is not an assessment.  (If you are looking for eSRA, please download the Handbook below).  GO TO THE SURVEY. Expand the article to read more...

eSRA Webinar Slides
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eSRA Webinar Slides

April 28, 2018

The webinar provided an overview of eSRA 2018.1, including: 1) EHR as eSource for Clinical Trials, 2) Regulations and Guidelines used as a basis for eSRA questions, 3) eSRA V2018.1, 4) eSRA -- The Future

Click on the title above to get to the download area.

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)
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Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Release 2018.1

eCF eSRA Release 2018.1 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan) and ICH (International). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA template questions should be updated.

Click on document title to download.

eSRA Use is Growing!
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eSRA Use is Growing!

Feb 2018 Statistics on use of eSRA around the globe

eClinical Forum has provided a free assessment tool for clinical research sites to self-assess their computerized systems for readiness to originate or handle data that could become part of a regulated clinical trial. This tool is called the "eSource-Readiness Assessment" or "eSRA" and has been available since August 2015. As of February 2018, it has been used by over 1140 sites in 47 countries.

Click on title to download complete statistics

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We are working on updating eSRA right now!

Sponsors & CROs -- Please take a few minutes to complete this brief survey regarding how your company reviews site healthcare systems. We would like the input of every company whether you are using eSRA or your own assessment or not assessing at all.

https://www.surveymonkey.com/r/Site_System_Assessment_Survey

The link/survey will only be active until the end of May 2019, but we encourage you to complete the survey before Friday, February 22 2019, as we need the information to improve the eSRA Version 2019 which will be available the first week of March. Responses after Feb 22, 2019 will be considered for the 2020 version.

Sites -- If you would like to provide feedback for the eSRA V2019, please describe your feedback in an email to esra@eclinicalforum.org 

Thank you in advance for your help!

eClinical Forum eSRA Team (comprised of members from Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, OmniComm, Pfizer)

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Technology Showcase: eClinical Solutions -- Enabling D-Clinical - Digital Data Strategy and the elluminate Clinical Data Hub

This webinar will share 

  • Key drivers enabling digital transformation in Life Science
  • Importance of digital data strategy within life sciences 
  • How Clinical Data Hub technology platforms like elluminate support Digital Data Strategies 
  • Demonstration of the elluminate Clinical Data Hub capabilities including data ingestion, standards mapping, aggregation and analytics. 
Read more
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