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

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

  • 1 October 2019
  • Author: Webmaster
  • Number of views: 6068
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Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .  July 8, 2019

The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) 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

eSRA Slides suitable to present to your organization

  • 15 July 2019
  • Author: Webmaster
  • Number of views: 4082
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eSRA Slides suitable to present to your organization

eCOA Data Changes

Best Practices for eCOA Data Changes

  • 14 May 2019
  • Author: Webmaster
  • Number of views: 1556
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eCOA Data Changes

Best Practices for eCOA Data Changes

Requirements for Electronic Data for Regulated Clinical Trials V2018PR

  • 29 March 2019
  • Author: Webmaster
  • Number of views: 1075
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Requirements for Electronic Data for Regulated Clinical Trials V2018PR

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. 

Audit Trail Review

  • 29 January 2019
  • Author: Webmaster
  • Number of views: 1887
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Audit Trail Review

Best practices for meeting regulatory expectations for Audit Trail Review

Archiving and Decommissioning

Developing a position paper from the industry on the electronic archiving of study data and related topics

  • 29 January 2019
  • Author: Webmaster
  • Number of views: 1484
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Archiving and Decommissioning

Developing a position paper from the industry on the electronic archiving of study data and related topics

CANCELED: eClinical Forum Europe Meeting in Helsinki, Finland

27-29 April 2020

  • 1 January 2019
  • Author: Webmaster
  • Number of views: 2362
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CANCELED: eClinical Forum Europe Meeting in Helsinki, Finland

This meeting is being replaced with a Virtual Global Workshop on 11-13 May 2020.

Networking with peers has never been more important in order to stay current, collaborate on shared challenges and influence the future. The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives.

For more information on our Virtual Global Workshop, please contact info@eclinicalforum.org.

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BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing: “Can we develop best practices for implementing standards across sponsors and CROs of all sizes to drive efficiencies that result in medical advancements getting to patients faster?”

  • Can we facilitate a mechanism to share standards across organizations to avoid process changes from one trial to the next?
  • Can we track standard utilization across organizations to be data driven about when and how updates are needed?
  • With the increase in digital trials, what additional standards should we be considering?
  • What does an optimal standards committee look like? 
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