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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.
Event date: 17/06/2020 Export event
Birds-of-a-Feather Webinar: Agile Development for Clinical Research Software
Date: Wednesday, June 17, 2020 Duration: One hour
Facilitator: Alan Yeomans, Quality Manager, Viedoc Technologies AB
Open To: Staff from eClinical Forum member companies gratis. Member can get registration information by sending a note to webmaster3@eclinicalforum.org. (If you are not an eCF member, please review the Membership tab on this website or contact info@eclinicalforum.org )
For This Topic: Agile computing methods and tools are used in almost all software development today. Alan will address some of the key issues involved when using agile methods and tools for the development of clinical research software:
• What is agile software development?
• What are the advantages of agile development?
• What should agile developers have when working with GxP software – in order to fulfil regulatory requirements?
• How does a sponsor audit such a system?
The theory behind how agile software development can be used for clinical research software will be followed with an example of a working development methodology incorporating agile methods and tools – how does a real software development organisation implement these methods and tools while maintaining regulatory compliance?
Time: This webinar will be offered twice so that all eCF members around the world will (hopefully) be able to join during a convenient time.
Webinar A: Europe and Asia Pacific Facing -- UTC 0700
Webinar B: Americas and Europe Facing -- UTC 1600
NOT A MEMBER?
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)
Japanese translation of eSRA V2022
Version 2022.1JP1 (10-May-2022)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
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.
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022
We are pleased to announce that registration is open for our hybrid workshop at the Old York Cellars in Ringoes, NJ on June 8-10 2022. We are very excited that we can offer this safe and fun venue as we will be meeting in an open-air event tent amidst their beautiful vineyard. 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 as well as evening networking events. For those who cannot join in person, some of the sessions will be live-streamed and recorded.