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NEWS FROM THE ECF

Views & News -- August 2022

eCF's monthly e-newsletter - “Keeping you Current”

Views & News -- August 2022

eCF Views: Threads on the Discussion Forum (please contribute!) MEMBERS AREA (eclinicalforum.org) … you will need your un/pw. If you don’t have a un/pw for our website, please use the “Register” button at the top right corner of the home page to request an account. It will take up to 48 hours for your account to be approved and activated. Anyone from an eCF member company can have a members account!

  • Recent questions waiting for responses … (all contributions have value – even if it is just to say your organization is not doing something. Thanks for participating!!)
    • Use of Textbook Ranges for local lab studies
    • o Investigator confirmation of causality/relationship
    • e-Archival at sites – what are the challenges?
    • What is the position of the regulatory authorities on the use of paper-based backups to ePRO/eCOA
    • Your question – please post a question for your eCF colleagues to respond to!
  • Workshop Recordings from Brussels (May) and New Jersey (June) have been removed from the website to conserve space but are still available via request to Adam.Perkins@eclinicalforum.org

 

eCF News:

  • We have some great webinars lined up for the next few months:
    • Aug 10th at UTC 1400. “Measuring Clinical Trial Data Quality”, a one-hour Birds-of-a-Feather Round-table discussion facilitated by Diego Gayon of Merck. For more information and to register: eCF BoF Round-Table Registration (eclinicalforum.org)
    • Sept 7th at UTC 1400.  “Tying Passive Data Collection to Active Mobile Measurements”, a one-hour Technology Showcase presented by Joan Severson of Clinical ink. This Tech Showcase will showcase Clinical ink and the value of passive data collection in clinical research by tying the rich, voluminous patient data compiled by mobile sensors and wearables to active mobile measurements, as well as highlighting voice data collection and processing, multimodal signal processing, and digital biomarkers. Technology Showcases have been requested by eCF members and are not, by nature technology neutral, however eCF does not endorse any particular technology. For more information and to register: eCF Technology Showcase Registration (eclinicalforum.org)
    • Recording available:  Using RWD and RWE in Clinical Trials”, a one-hour panel discussion (on July 13th) was facilitated by Ken Light of Clinscape, with panelists from the RWE/RWD Clubhouse “Real -World Wednesdays”, Matt Veatch and Dr. Aaron Kamauu, and “eCF-er” Dave Stein. Contact webinars@eclinicalforum.org for a link to this recording.
  • Our next eCF Hybrid Workshop dates announced! Please save the dates!
    • Europe: Uppsala, Sweden on 4-6 October 2022 kindly hosted by Viedoc Technologies
    • Asia-Pacific: Tokyo, Japan on 25-26 October 2022 kindly hosted by Bristol Myers Squibb
    • Americas: West Point, Pennsylvania on 14-16 November 2022 kindly hosted by Merck & Co.
    • Stay tuned for more information on these hybrid workshops. We are now accepting suggestions for topics and offers for presentations. Please contact Richard Perkins (EU workshop), Ken Nakano (Asia Pacific workshop) or Suzanne Bishop (Americas workshop). See email addresses below.
  • New e-ISF (e-Investigator Site File) Team is forming! We will continue the work started at the Brussels and New Jersey workshops to develop a questionnaire for sites to evaluate their eISF systems against regulatory requirements and recommendations. This team will be under the guidance of the eCF REG team and chaired by Ronit Elshtein of Pfizer. Please contact the team liaison Suzanne.Bishop@eclinicalforum.org for more information and/or to volunteer to participate in this team.
  • New DCT (Decentralised Clinical Trials) Team is forming!  New DCT (Decentralised Clinical Trials) Team is forming!  This team will consider the strategic, regulatory, process and technology environment for DCT by evaluating the state-of-the-art technology together with emerging trends.   This team will be a joint effort with EUCROF.  Please contact the team liaison Kenichi.Nakano@eclinicalforum.org more information and/or to volunteer to participate in this team.
  • Did you know that eCF offers a comprehensive list of compliance requirements for evaluating electronic systems that will manage data used in regulated clinical research against regulations and guidances from FDA, EMA, PMDA, MHRA, NMPA and ICH.  We call this the “eCF Requirements”. This work is a result of the vast experience of the REG team members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document. The 2022 version is available to eCF members only – if you haven’t looked at it yet, you really should take a look and pass this valuable tool on to your organization colleagues. Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2022 (eclinicalforum.org)

eCF Views & News is a monthly newsletter of the eClinical Forum (www.eclinicalforum.org) to keep our members informed. All members are welcome to contribute. If you want to contribute or subscribe/unsubscribe, please contact webmaster3@eclinicalforum.org

Your eCF facilitators are always interested in what you have to say … Richard.Perkins@eClinicalForum.org, Suzanne.Bishop@eClinicalForum.org, Kenichi.Nakano@eClinicalForum.org. Technical or Administrative inquiries should be directed to Adam.Perkins@eClinicalForum.org.

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«August 2022»
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HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

We are pleased to announce our next Workshops:

- Europe: Uppsala, Sweden on 4-6 October 2022 kindly hosted by Viedoc Technologies

- Asia-Pacific: Tokyo, Japan on 25-26 October 2022 kindly hosted by Bristol-Myers Squibb

- Americas: North Wales, Pennsylvania on 14-16 November 2022 kindly hosted by Merck & Co.

The workshops will be available for face-to-face and remote participation. We will soon be in touch with registration details but in the meantime please save the dates in your calendar.

We are building exciting agendas for the meetings. If you can contribute or have topics to propose, then please get in touch.

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Views & News -- August 2022

Views & News -- August 2022

We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org.   Click "Read More" to see this month's "Views & News"!

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eClinical Forum APAC Workshop

eClinical Forum APAC Workshop

This meeting is kindly hosted by Bristol Myers Squibb and held in a facility near the Tokyo Station.  We are currently accepting suggestions for agenda topics and/or presenters in the areas of  Decentralized Clinical Trials, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.

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Birds-of-a-Feather Round Table Discussion:  Measuring Clinical Trial Data Quality

Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality

We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.

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