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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.
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BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity
Join us for a discussion of the eCF/SCDM industry position paper on the use of audit trail review as a key tool in ensuring data integrity. We will share our thoughts on the rationale, opportunities and challenges, along with practical implementation recommendations.
Presenters: Linda King, Astellas, eCF Audit Trail Review Team
Miko Pietilä, Signant Health, eCF Audit Trail Review Team
REGISTRATIONS CLOSED: eClinical Forum Virtual Workshop, 12-16 October 2020
We are pleased to announce the details of our next Virtual Global Workshop on 12-16 October 2020 (which replaces our planned Global Workshop in Dublin which is postponed until 2021). The virtual workshop will include a mix of global and regional events and is open to participants from any member company in any region.
Our last virtual workshop was a great success and this one will be even better. We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of global sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE
BoF Round-table: Master Protocol Trial Designs & Data Management Considerations
Facilitator: Sara Hale, Amgen
Since the release of the FDA guidance for Adaptive Clinical Trial Design, many Sponsors have been working to enable Master Protocol trials. The MP designs includes 1. Basket Trial Design 2 Umbrella Trial Designs and Platform Trial Designs, which more complex in nature in that they are inclusive of multiple sub-studies within a single trial that within a traditional designs would have been separating out into separate trials. Making it necessary to consider fit-for-purpose strategic operational, process and system solutions.