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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

eCF Autumn 2018 Meeting Dates and Locations Announced

  • 20 February 2018
  • Author: Webmaster1
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eCF Autumn 2018 Meeting Dates and Locations Announced

North America: Oct 2-4 in Philadelphia, Pennsylvania USA hosted by CRF Health

Europe: Oct 23-25 in Paris, France hosted by Servier

Asia Pacific: Nov 5-6 in Tokyo Japan

Agendas will be decided a few months prior. For more information or to suggest agenda topics, please contact info@eclinicalforum.org

eCF Asia 2017 Workshop. Hosted by Quintiles IMS, Tokyo, 4-5 Dec 2017

HOLD THIS DATE

  • 12/4/2017 - 12/5/2017
  • Author: Webmaster1
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eCF Asia 2017 Workshop. Hosted by Quintiles IMS, Tokyo, 4-5 Dec 2017

We are happy to announce that our next meeting of the Asia Pacific Forum will be held at Quintiles IMS in Tokyo, Japan on 4-5 October 2017. Thank you to Quintiles IMS for hosting us in such a nice location.

A Preliminary Agenda will be available very shortly. Please send suggestions for topics/presenters to info@eclinicalforum.org.

Birds-of-a-Feather and Tech Showcase Recordings

  • 25 July 2017
  • Author: Webmaster1
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Selected events are recorded and are available un-edited for member use only within the "BoF & TS Recordings" folder below.  Not all events will be recorded or released. Recordings are un-edited and are provided for eCF member use only.  Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors.

eCF Europe 2017 Workshop. Hosted by Bayer, Berlin, 26-Sep to 28-Sep 2017

Location: Steigenberger Hotel Berlin

  • 9/26/2017 2:00 PM - 9/28/2017 4:30 PM
  • Author: Webmaster1
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eCF Europe 2017 Workshop. Hosted by Bayer, Berlin, 26-Sep to 28-Sep 2017

We are happy to announce that our Autumn meeting will be held at the Steigenberger Hotel in Berlin, Germany on 26-28 September 2017. Thank you to Bayer for hosting us in such a nice location.

A Preliminary Agenda will be sent in July. Please send suggestions for topics/presenters to info@eclinicalforum.org.

ECF REPRESENTATIVES MEET WITH EMA GCP IWG

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

  • 15 June 2017
  • Author: Webmaster
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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

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...

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BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

The implementation of new solutions to share electronically the eCRF PDFs with sites have brought up new considerations and challenges to this process.

We would like everyone to share their experiences on how the process has been implemented, as well as the challenges experienced. This will be a group discussion on the recommendations to make this process as straight forward as possible for Sites and Sponsors, while complying with requirements.

Facilitated by Carmen Jiménez, Eli Lilly

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Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”.  This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. The position paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.

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Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

This webinar introduces the NEW "Practical Guide to eConsent" which addresses key themes and hots topics and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic.  This is a joint work by the eClinical Forum and EUCROF.

 

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Birds-of-a-Feather Round Table Discussion:  “When does audit trail begin?”

Birds-of-a-Feather Round Table Discussion: “When does audit trail begin?”

Audit trails create a step-by-step record of data back to its source. It is utilized when the integrity and confidence of the datapoint has critical/legal significance. It is important to determine and declare when data entry becomes “real” data. In legacy paper, data is manually recorded, but only becomes “real” when it is signed, submitted, or completed. Signatures and confirmations also exist to add additional credibility to the source. If a paper form is being filled, it is considered draft until it is declared complete by the originator. The originator has the option to crumple up the “draft” paper and start another without question. The same should hold true with electronic data entry as this webinar will discuss.

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