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  • Brussels 15-17 May 2019
    Brussels 15-17 May 2019
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    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
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    REYKJAVIK 8-10 MAY 2017
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    BLUE BELL, PA 24-26 OCT 2016
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    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
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    NORTH WALES, PA 18-20 MAY 2015
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    SIENA 28-30 APR 2015
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    BANGALORE 5-6 FEB 2015
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    CAMBRIDGE, MA 22-24 OCT 2014
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    COPENHAGEN 16-18 SEP 2014
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    SINGAPORE 20-21 MAY 2014
  • AMSTERDAM 14-16 MAY 2014
    AMSTERDAM 14-16 MAY 2014
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    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
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    EAST HANOVER, NJ 7-8 MAY 2012
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    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
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    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.


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Regulatory

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"
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eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"

V2018PR March 2019

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. 

To download this file, click on the Downloads tab at the top of this website page.

For more information on the free public webinars, click the title of this article.

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.

Birds-of-a-Feather Discussion:  ICH-E6 (R2) and Industry Adoption of RBM
  • 2026
  • Article rating: 5.0

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

19-June-2018 via webinar (one hour)

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.

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only
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Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

eCF Members Release 25-March-2019

The eClinical Forum is happy to announce the V2019 Members-Only release of the “eCF Requirements”. 

The eCF Requirements are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if data which will become part of a regulated clinical trial are consistent with regulatory requirements. The V2019 Members Release has 21 documents mapped.

Click title for more information

ECF REPRESENTATIVES MEET WITH EMA GCP IWG
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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation…  Expand article to read more...

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event
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Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

Event Feedback

We had a fabulous level of participation with well over 140 members online from California to Japan participating in our first webinar of 2017 on the release of the addendum to E6 (Good Clinical Practice), 20 years after its original publication. Some good discussion helped us to understand the changes, opportunities and challenges. Expand the article to read more about the event.
FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016
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FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016

Re-Posted from eCF LinkedIn Group

The FDA and OHRP published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent. Expand the article to read more

Free access to GCDMP
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Free access to GCDMP

Re-Post from eCF LinkedIn

Anyone can now access to this important document for Data Management and Clinical Research.
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5/15/2019 - 5/17/2019 UTC
74

AGENDA AVAILABLE: eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum will take place in Brussels 15-17 May 2019.

Come along and see why our members are so excited... "ECF are the only meetings I attend each year. It gives me everything I need to stay current and to answer my questions"  "People were amazing. Topics were great" 

Please register your interest or contact the eCinical Forum for more information.

Expand the article for agenda and further details...

Read more
16
5/15/2019 - 5/17/2019 UTC
74

AGENDA AVAILABLE: eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum will take place in Brussels 15-17 May 2019.

Come along and see why our members are so excited... "ECF are the only meetings I attend each year. It gives me everything I need to stay current and to answer my questions"  "People were amazing. Topics were great" 

Please register your interest or contact the eCinical Forum for more information.

Expand the article for agenda and further details...

Read more
17
5/15/2019 - 5/17/2019 UTC
74

AGENDA AVAILABLE: eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum will take place in Brussels 15-17 May 2019.

Come along and see why our members are so excited... "ECF are the only meetings I attend each year. It gives me everything I need to stay current and to answer my questions"  "People were amazing. Topics were great" 

Please register your interest or contact the eCinical Forum for more information.

Expand the article for agenda and further details...

Read more
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