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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

Requirements for Electronic Data for Regulated Clinical Trials V2018PR

  • 29 March 2019
  • Author: Webmaster1
  • Number of views: 85
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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. 

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

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

  • 25 March 2019
  • Author: Webmaster1
  • Number of views: 1539
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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

We are happy to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. This 2019 version 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.

Click on the tab in the top-right of this website (www.eclinicalforum.org) "eSource Readiness Assessment (eSRA)".

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

Better Together

  • 5/15/2019 - 5/18/2019
  • Author: Webmaster1
  • Number of views: 3595
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eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum took place in Brussels 15-17 May 2019, kindly hosted by Janssen.  The rousing meeting was well attended by members from Actelion, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, CRF Bracket, CSL Behring, Eli Lilly, eResearch Technology, Glaxo SmithKline, Idorsia, Janssen Pharmaceuticals, Medidata, Merck KGaA, Munich Technical University, Neptunus Data, Novartis, Novo Nordisk, Oracle, Orion, Servier, Wega Informatik, ZeinCRO ... and guests Association for Innovative Medicines, ECRIN, and European Patients' Forum.  Meeting participants rated this meeting highly successful once again!

eCF North America Spring Meeting 2019

April 8-10 2019 hosted by Boehringer Ingelheim in Ridgefield CT

  • 4/8/2019 - 4/11/2019
  • Author: Webmaster1
  • Number of views: 4253
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eCF North America Spring Meeting 2019

The North American Spring Meeting was held at Boehringer-Ingelheim in Ridgefield CT on April 8-10 2019.   Attendees were from Actigraph, Allergan, Astellas, Bioverativ, Boehringer-Ingelheim, Bristol-Myers Squibb, BSI Business Systems Integration, Cardinal Solutions, Cenduit, CRF Bracket, CSL Behring, Diligent Pharma, eClinical Solutions, Eli Lilly, ERT, Health Quest, ICON, Merck & Co., Neptunus Data, Novartis, Pfizer, Target Health, Veeva and West Connecticut Health Network. The meeting was rated by the attendees as 4.8/5.0 with comments "Great Forum again! Relevant topics and participants are SMEs or at least willing to share experiences.", "You get better every year! This was a STELLAR meeting -- Great faciliticies, events and attendees/presenters!", "Excellent meeting. It was my first eCF meeting but I hope to attend many more. Great group. I learned a great deal.", :Awesome meeting!"  Slides and meeting output are available to members -- please contact webmaster3@eclinicalforum.org. 

See you at our next meeting hosted by Pfizer in Peapack, NJ on Oct 14-16 2019!

Announcing Autumn 2019 Meeting Dates

  • 10/14/2019 - 10/17/2019
  • Author: Webmaster1
  • Number of views: 4195
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Announcing Autumn 2019 Meeting Dates

Save the date!!

Oct 14-16 2019 in Peapack, New Jersey USA. Kindly hosted by Pfizer

Oct 28-30 2019 in Zurich, Switzerland EU. Kindly hosted by Business Systems Integration (BSI)

Dec 2-3 2019 in Tokyo, Japan. Kindly hosted by Eli Lilly

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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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