Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

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.

The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial.

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).

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.

The eClinical Forum REG Team has completed a significant update to the Members-Only 2023 release of the eCF Requirements for Electronic Data for Regulated Clinical Trials (commonly referred to as the “eCF Requirements”).  This updated release incorporates extensive review and mapping of the EMA Guideline for Computerised Systems and Electronic Data in Clinical Research. This document is invaluable in determining if electronic records and systems are appropriate for use in regulated clinical trials.

This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Veeva Systems, an eClinical Forum member company, will showcase their end-to-end solution for patients, sites, and sponsors. The eClinical Forum does not promote nor endorse any particular technology vendors.

This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Viedoc Technologies, an eClinical Forum member company, will showcase their e-Trial Master File/e-Inestigator Site File solution. The eClinical Forum does not promote nor endorse any particular technology vendors.

The facilitators will share their experiences with the Boehringer-Ingelheim audit trail review tool … how it was developed, how it is being used, and what are the benefits. They welcome and encourage an open discussion on what tools and procedures other organizations are using for audit trail review.

A member from each eCF Project Team will present significant items in this guideline, from the perspective of their team topic.

Developing a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations.

Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?"  It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

We welcome feedback! Please send to: REG@eclinicalforum.org