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.

 

NEWS FROM THE ECF

eCF Americas Autumn Workshop 2024 Announced

October 22-24 2024

eCF Americas Autumn Workshop 2024 Announced

Save the date!  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 Views & News

June 2024

eCF Views & News

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.

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Wednesday, 26-June-2024      UTC 1400, Duration: One hour

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

Assessing Investigator Site File Systems for Clinical Research

By Pablo Perez, Lead Quality Assurance Data Integrity, Astellas

A brief overview of who should use the eCF's newest assessment tool ... and why. This article can be viewed or downloaded by clicking "read more".

New eCF ISF System Assessment!

New eCF ISF System Assessment!

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.

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

24 March 2024 Public Release

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

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.

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

Thursday, 21-March-2024      Duration: One hour

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

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. 

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.

Essential Metadata

New eCF Project

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.

eCF Spring Workshop in Ridgefield, Connecticut USA

April 30 to May 2, 2024

eCF Spring Workshop in Ridgefield, Connecticut USA

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.

eCF Spring Workshop in Zurich, Switzerland

April 16-18, 2024

eCF Spring Workshop in Zurich, Switzerland

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.

Public Webinar: Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

Joint C-Path/eCF Project Team Webinar: 6-Feb-2024

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).

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eCF Views & News

eCF Views & News

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.

Read more
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eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

Read more
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