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Event date: 11/10/2020 Export event
Birds-of-a-Feather Webinar: Measuring and validating real-world mobility – Easier said than done
Date: Tuesday 10-November, 2020 Duration: One hour Time: UTC 1500
Presenter: Beatrix Vereijken (Norwegian University of Science and Technology) and Valdo Arnera (ERT Technology)
Open To: Staff from eClinical Forum member companies gratis (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )
Background: eClinical Forum webinar sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
For This Topic:
Mobility is an important marker of health, key to our independence, and a major driver for quality of life. Many aspects of how we walk can be easily measured and quantified in a well-equipped scientific or clinical laboratory, but this ‘artificial snapshot in time’ is a poor indicator of how well we move about in the real world. Recent advances in digital technologies have opened the door to monitoring mobility 24/7 but going beyond the number of steps or the vigour of moving has shown remarkably difficult. Yet, accurate assessment of daily life mobility in clinical trials and patient treatment is necessary for improved and more personalised care, but what is required to get there? In this webinar, we will address the following topics:
eClinical Forum members can register via this link: ! https://eclinicalforum.org/Forms/eCF-Webinar-IMI-Mobilise-D-Real-World-Mobility-Measurement
Not an eCF member? Please contact info@eclinicalforum.org for more information
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Birds-of-a-Feather Round Table Discussion: New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data
In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.
The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.
BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download
The implementation of new solutions to share electronically the eCRF PDFs with sites have brought up new considerations and challenges to this process.
We would like everyone to share their experiences on how the process has been implemented, as well as the challenges experienced. This will be a group discussion on the recommendations to make this process as straight forward as possible for Sites and Sponsors, while complying with requirements.
Facilitated by Carmen Jiménez, Eli Lilly
