"This is the best use of my time to remain current with what is going on in the industry."
WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
Team started in August 2024. The goal is to review, prioritize and standardize the audit trail review data checks based on the eCF ATR position paper (2021) and create a list of high impact checks that can be implemented by sponsor companies and technology vendors.
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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.
Questions from eSRA Users
This is a categorised list of questions sent in from eSRA users (sites, sponsors, CROs) with the response from the eClinical Forum eSRA Team.
eClinical Forum has released the 2024 version of their “eSource Readiness Assessment” – eSRA
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.
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.
Audit Trail Review Analytics (ATRA)
EU Hybrid Workshop Announced
Registration is open! Our EU Hybrid Workshop will be kindly hosted by Boehringer Ingelheim at their offices in Ingelheim am Rhein, Germany on October 15-17 2024.
eCF Americas Autumn Workshop 2024 Announced
Registration is open! Our Americas Autumn workshop will be kindly hosted by eClinical Solutions at their offices in Mansfield, Massachussetts (near Boston/Patriots Stadium) on October 22-24 2024.
eCF APAC Autumn Workshop 2024 Announced
Registration is open! Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.