eCF Views & News -- April 2023 "Keeping you current"

eCF Views:

Some new discussions, looking for your thoughts …

• CRF Standards
• eCRF Instructions
• Use of paper diaries / questionnaires over electronic solutions
• Validation of an Operational Data Warehouse

And, some older discussions, still worthwhile … so login Discussion Forums (eclinicalforum.org) and let us know what you are thinking!  (reminder … if you don’t have an account, register via the button on the top right of the home page … www.eclinicalforum.org )

eCF News:

• The eCF REG team has released the 2023 “eCF Requirements” (Requirements for electronic data for regulated clinical trials).  The 2023 version is limited to eCF members companies who have paid their 2023 membership fee. The 2022 version has now been released to the public via our website. Congratulations to the REG Team for a job well done: Alan Yeomans, Neil Konopka, Yiannis Karageorgos, Valdo Arnera, Evan Grunbaum, Devry Spreitzer, Nigel Boneham, Jules Mitchel, Greg Gogates, Valeria Orlova, François Caijo, Mireille Muller, Aditya Suripeddi, Ken Nakano, Suzanne Bishop. For more information, please contact reg@eclinicalforum.org

• The 2023 version of eSRA is out! This “eSource Readiness Assessment” is being used by sponsors and sites around the globe to determine if a site’s eSource systems (EHR/EMR, labs, etc) is appropriate to source data for clinical research.  It is based on the eCF Requirements V2023. The new version of eSRA can be downloaded for free by members and non-members at eSRA (eclinicalforum.org). Congratulations to the eSRA Team for a job well done: Cecilie Moe, Yvonne Rollinger, Ronit Elshtein, Poh Chiam Sim, Yiannis Karageorgos, Ewa Ott, Mei-Li Meas, Faisal Sufi, Ken Nakano, Suzanne Bishop. To join this team, please contact esra@eclinicalforum.org.
• eCF Technology Showcase! April 18th at UTC 0700 and UTC 1500.  “Onboarding a combined CTMS and eTMF”, a one-hour Technology Showcase presented by Michael Leong, Stefan Vogt, Jan Nielsen of BSI Life Sciences. They will share their thoughts on why a unified CTMS and eTMF is crucial in running clinical trials in the age of digitization and technology, while providing examples with the BSI  CTMS and eTMF.  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: BSI Life Sciences - "Onboarding a combined CTMS and eTMF” (eclinicalforum.org)
• eCF Spring Workshops have been planned for America and Europe.  These will be in-person workshops with live-streaming for those who cannot join in-person. Topics include Decentralized elements in CT, AI use cases in CT, Archiving & Decommissioning, External Data Sources, and more. Each member company within the region has one or more in-person seats available for the workshop (gratis), and additional seats can be purchased.  Virtual seats are gratis to all eCF members.
  • Americas Workshop is hosted by Signant Health in Blue Bell, PA on May 15-17.  Information and registration: eClinical Forum Hybrid Workshop, Blue Bell, PA May 15-17, 2023.  For additional information, please contact Suzanne Bishop.
  • Europe Workshop will be 14-16 June 2023 in Darmstadt, Germany.   Information and registration: eClinical Forum Hybrid Workshop, Darmstadt, Germany June 14-16, 2023. For additional information, please contact Richard Perkins.
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  • Free FDA Webinar: Electronic Systems, Electronic Records, and Electronic  Signatures – 25 April 2023 at 3pm EDT (1900 UTC). Registration and information: Electronic Systems, Electronic Records, and Electronic Signatures Webinar - 04/25/2023 | FDA