"This is the best use of my time to remain current with what is going on in the industry."
It is a response to the growing expectation by regulatory agencies for clinical trial sponsors to verify that clinical research site systems (e.g., EHRs) comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment. V2024 includes updates based on the EMA Guideline on computerised systems and electronic data in clinical trials.
Essential Metadata
The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial.
eClinical Forum has released the 2024 version of their “eSource Readiness Assessment” – eSRA
Public Webinar: Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes
The joint C-Path/eCF Project Team is pleased to present a public webinar on their recently published article “Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes” in the peer-reviewed SCDM Journal “Digital First”: Delong | | Journal of the Society for Clinical Data Management (jscdm.org).
eCF Birds-of-a-Feather Webinar: Measuring real-world mobility
Measuring daily life mobility in patients reliably is a complicated affair – but not impossible. This presentation provides insight into what it takes to establish technical validity, clinical relevance, and acceptance of digital mobility outcomes using wearable technology. Mobilise-D is a project of the Innovative Medicines Initiative (IMI), the world’s biggest public-private partnership in the life sciences. This is an eCF-member-requested topic.
Birds-of-a-Feather Round-table on eCOA Topics
Open To: Staff from eClinical Forum member companies gratis (If you are not an eCF member, please review our website Membership for membership information or contact info@eclinicalforum.org )
eCF Webinar: "Strategies for Implementing Audit Trail Review"
The eCF Audit Trail Review Analytics (ATRA) team anticipates releasing their white paper "Strategies for Implementing Audit Trail Review" to eCF members in early September. This webinar will provide an overview of the paper as well as delve into some specific areas.
eCF Autumn Workshops Announced!
We are happy to announce our 3 Autumn workshops!
Americas: Hosted by Eli Lilly in Indianapolis on October 21-23
Europe/Hybrid: Hosted by Medidata in London on Nov 4-6 (this will be livestreamed as well)
Asia: Hosted by Kyowa Kyrin in Tokyo on Nov 13-14