eCF Views: Members want to know … what’s YOUR VIEW on these topics in our members-only online Discussion Forum?

• • Use of Textbook Ranges for local lab studies
  • 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!
• Discussion Forums (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 (if you’ve received this email, then that’s you!)

eCF News:

     eCF Workshops:

• The European workshop is just around the corner! It will be hosted by Viedoc Technologies in Uppsala, Sweden on 4-6 October. It will also be live-streamed. It’s not too late to register, however on-line registration is now closed … please contact Adam Perkins for registration and agenda information. Live-streamed participation is gratis to anyone in an eCF member company.
  • The Asia-Pacific workshop will be in Tokyo, Japan on 25-26 October 2022, hosted by Bristol Myers Squibb. This is an in-person workshop which will be recorded (not live-streamed). The recordings will be available the following week. Please contact Ken Nakano for agenda information.

Online registration:  Workshop Tokyo 25-26 October 2022 (eclinicalforum.org)

• • The Americas workshop will be hosted by Merck & Co in North Wales, Pennsylvania on 14-16 November. It will be in-person and live-streamed. In-person participation is per member company seat allocation; live-stream is unlimited and gratis to anyone in a member organization. Please contact Suzanne Bishop for agenda information.

Online registration: eCF Hybrid Workshop Pennsylvania USA Nov 14-16 2022 (eclinicalforum.org)

eCF Technology Showcases:

• Recording available for the Technology Showcase given by Joan Severson of Clinical ink on Sept 7th: “Tying Passive Data Collection to Active Mobile Measurements. If you want the link, please send email to webinars@eclinicalforum.org
• What is an eCF Technology Showcase?  The eCF is a non-profit, non-commercial organization and by policy we do not endorse or promote any particular technology solution … which is why you will never see a vendor-booth area or hear a marketing presentation at our workshops. However, we are “for the members and by the members” and several years ago, the members requested to see the products and services offered by our vendor members, so we decided to host Technology Showcases via a one-hour webinar. Any member can present and any member can participate as they wish. However the vendor hosting the event cannot market directly to those who attend … so no follow-up contacting. This seemed to be a win-win and the eCF Technology Showcases have been very popular! They are always recorded … see the list here: eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022 (eclinicalforum.org)

• FDA has issued a draft guidance on Computer Software Assurance for Production and Quality System Software | FDA on 13-Sep-22. The eCF REG team is reviewing and will be submitting comments by the deadline of 14-Nov-22.
• The eCF PI Signature team released “Best Practice Document on Investigator’s Signature” as a members-only release on 7-Apr-22. As per eCF policy, eCF members have 6 months exclusive access prior to a public release. The document was released to the public on 1-Oct-22 and can be downloaded from our website in the “News” section: Best Practice Document on Investigator’s Signature (eclinicalforum.org). Congratulations to team leaders Cinzia Piccini (Eli Lilly) and Babette von Hagen (CSL Behring) and to the whole PI Sig Team for this significant work.  Please feel free to share this widely!

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. Please feel free to forward this email to your colleagues. 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.