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  • 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.

 

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.

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

Report: Summary of Site Readiness for CR Source Data
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Report: Summary of Site Readiness for CR Source Data

Summary of eSRA Responses: October 2015 through March 2018

Stay Tuned! We will be compiling and analyzing the eSRA responses from eSRA Release 1 (October 2015 through March 2018). Data will be presented in an anonymized and summarized form. We hope to identify areas for improvement within the e-Clinical arena.  We anticipate this report to be ready June 2018.

Netherlands initiative to assess electronic health record systems using eCF eSRA tool
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Netherlands initiative to assess electronic health record systems using eCF eSRA tool

Partnering for Success

The Dutch Clinical Trial Foundation (DCTF) evaluate the use of eSRA for the validation of electronic health record (EHR) systems used at clinical research sites within the Netherlands. The group consists of representatives from several pharmaceutical companies, CROs and hospitals. Expand the article to learn more...

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Birds-of-a-Feather Discussion:  ICH-E6 (R2) and Industry Adoption of RBM

Presenters:  Abby Abraham and Ken Light, OmniComm Systems

Open To: Staff from eClinical Forum member companies  (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum Birds-of-a-Feather sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

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