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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 "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

Select recordings available

eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together.  Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.

The following topics have been discussed in the past 2 years. Those with an asterisk * have been recorded, and are available to eCF members on this website in the Members-Only Document Repository (must sign in to access) or by sending a note to webmaster3@eclinicalforum.org.  Round-table discussions are not recorded, to allow for a greater dynamic in the group discussion.

2020

  • Investigator Oversight on eCOA data - what is a good evidence?
  • Sponsor responsibility to Assess Investigator Site Systems & eSRA *
  • Industry Standard HL7 FHIR as used to integrate Sponsor’s EDC system with Site’s EHR System *
  • Subject Status Calculations
  • Tufts/eCS Survey: Data Strategy Transformation *
  • Agile Development for Clinical Research Software *
  • Real World Evidence and Real World Data *
  • Technology Showcase: Automating the Clin Data Pipeline / eClinical Solutions *
  • US National Patient Identifier
  • eSRA Japanese Language Webinar (Public) *
  • Audit Trail Review
  • Master Protocols
  • IMI Mobilise-D *
  • Technology Showcase: Lessons learned from a Covid19 Paperless Trial / Target Health *

2021

  • Investigator Signature / regulatory authority expectations
  • eCF Brews & News “#NoGoingBack”
  • Data Archival at Sites Using Direct Download
  • eConsent – Practical Considerations in Implementing *
  • “When does Audit Trail begin?”
  • Public Webinar: “eCF Requirements” and “eSRA” *
  • Utilization of Scribes in eCOA
  • Real World Data in Clinical Research and FDA projects (presented by Mitra Rocca of FDA) *
  • Audit Trail Review in Practice – Focus Session *
  • eClinical Standards - Best Practices for implementing
  • Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity *
  • Best Practice Recommendations for Changing eCOA Data *

2022

  • Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials *
  • Electronic Investigator Site Files (eISF)
  • Technology Showcase: Creating a Foundation for Digital Trial Data / Veeva *
  • Suppliers/Vendors Oversight: Best Practices
  • Technology Showcase: Leveraging a Digital Accelerator  / eClinical Solutions *
  • Principal Investigator's Signature: Best Practices
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eCF BoF Webinar: Principal Investigator's Signature: Best Practices

eCF BoF Webinar: Principal Investigator's Signature: Best Practices

 The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April.  They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs).  Participants are encouraged to share their thoughts on:

- how to provide continuous monitoring of regulatory expectations;

- sharing members’ experience on implementation and regulatory findings (if any);

- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.

Presenters:   eCF PI Signature Team Leaders:  Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)

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Japanese translation of eSRA V2022

Japanese translation of eSRA V2022

Version 2022.1JP1 (10-May-2022)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

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REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
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REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
19
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
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