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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

Birds-of-a-Feather Webinar:  Patient Engagement: Techniques, Tools and Technologies

Wed, March 27 at UTC 1300 and UTC 1900 (28-March at 6am for Sydney AUS)

Birds-of-a-Feather Webinar:  Patient Engagement: Techniques, Tools and Technologies

FacilitatorDavid Stein, D. Bartley Consulting

Opening StatementsJeff Lee, President, eCOA & Patient Engagement, CRF Bracket and Martin Collyer, “Patient Engagement” Consultant

Duration: one hour (offered at UTC 1300 and UTC 1900)   Note: Sydney AU will be at 6am local time on 28-March.

(click on title for more information)

What is the difference between the V2020 and V2019 eSRA?

Changes are minor -- see the list

While several additional regulatory documents were mapped to the eSRA questions, they did not significantly change eSRA between V2019 and V2020. No questions were added or deleted. Some question text were modified to improve clarity. Please download the file showing each question with it's change.

BoF Webinar: EHR to EDC for Automated Population of CRF

June 27 at UTC 1400

BoF Webinar: EHR to EDC for Automated Population of CRF

Where is your organization on the EHR to EDC journey?  Not started, early prototypes, other?

What is the principal value your organization expects from EHR to EDC one day? 

  • Getting patient data sooner than typical industry 8+ day lag time from visit to EDC data entry?
  • Higher quality data leading to less “back and forth”?  
  • Direct cost savings on SDV as data sourced from EHR doesn’t need to be SDV'd?

Come join us as we cover a perspective of some of the work happening across the industry to take advantage of this valuable Data Source.

Outcome: North America Spring Meeting May 1-3 2018

Hosted by Bristol Myers Squibb in Princeton NJ

Outcome: North America Spring Meeting May 1-3 2018

Our Spring North American meeting was held at Bristol-Myers Squibb in Princeton, New Jersey on 1-3 May 2018. Companies participating were Allergan, Allscripts, Array Bio-Pharma, Astellas, Bioverativ a Sanofi Company, Bristol-Myers Squibb, BSI Business Systems Integration AG, Cenduit, Cerner, CRF Health, CSL Behring, D. Bartley Consulting, eClinical Solutions, Elligo Health Research, Janssen Pharmaceuticals, Medidata, Novartis, Omnicomm, Oracle, Pfizer, Rutgers the State University of NJ, Target Health, Veeva. 

BoF Discussion: Direct Access to Sponsor’s Systems used in Clinical Investigations

Offered twice: Wed March 14 2018 for one hour at UCT 0800 and UTC 1700

BoF Discussion: Direct Access to Sponsor’s Systems used in Clinical Investigations

What are the considerations and challenges to grant such access in the Sponsor’s systems... Facilitated by Cinzia Piccini, Eli Lilly & Co.

This BoF Discussion is open to all from eCF Member companies. Please contact suzanne.bishop@eclinicalforum.org to register for this BoF or for information on eCF membership.

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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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