eClinical Forum now has 2 FREE assessment forms for sites to self-assess their systems for use in regulated clinical trials. We are excited to release the first version of the “ISF System Assessment”.   This assessment form is very similar to our eSource-Readiness Assessment (eSRA) and is, like eSRA, based on regulatory documents from regulators around the globe.

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023"

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

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.

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

This workshop is hosted by BSI Life Sciences at their office in Zurich, Switzerland on April 16-18. It will also be live-streamed and recorded for access by all eCF members.

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.

Congratulations to the joint C-Path/eCF :eCOA Best Practices" Team for publishing their paper “Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes”

 in the peer-reviewed SCDM Journal “Digital First”. 

Europe/Global hybrid workshop --  April 16-18

Americas in-person workshop -- April 30 - May 2