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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 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.

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.

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.

eCF REG Team has updated the "eCF Requirements" to include mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

Members Release MR2023.3

eCF REG Team has updated the "eCF Requirements" to include mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

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.

MR2023.3 of the "eCF Requirements" includes mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research and is available to eCF members only

Members Release MR2023.3

MR2023.3 of the "eCF Requirements" includes mappings to the EMA Guideline on Computerised Systems and Electronic Data in Clinical Research and is available to eCF members only

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.

eCF APAC Workshop -- All's well that ends well

eCF APAC Workshop -- All's well that ends well

eClinical Forum's two-day APAC Workshop was held in Kobe on 13 & 14-Nov-2023. The workshop was such a great success, thanks to generous and attentive hosting by Eli Lilly and thanks to all the participants from sponsors, investigator sites and system integrators who made contributions through thought-provoking presentations, intelligent comments/questions and friendly discussions. Thank you all and see you at next year's workshop!

eCF Americas Autumn Workshop -- loads of information, networking and fun

Hosted by Janssen in Spring House, PA October 24-26 2023

eCF Americas Autumn Workshop -- loads of information, networking and fun

eClinical Forum's Autumn Americas Workshop last week at Janssen in PA was terrific! It was so dynamic with participants from so many different eCF members companies presenting, discussing, networking and generally having a good time together. We had participants from Acadia, AiCure, Amgen, Astellas, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Clario, CSL Behring, Early Access Care, eClinical Solutions, GSK, J&J/Janssen, Medidata, Memorial Sloan Kettering, Merck & Co, Merck KGaA, Safira, and Uniphi. But, still we missed our members who could not attend ... Abbvie, Alexion, Ferring, Oracle, Novartis, Pfizer, Signant Health, and Veeva. I look forward to more collaborating over the winter and to be together in the Spring!

Congratulations to our Founder, Richard Perkins, on his retirement!!!

July 1, 2023

Congratulations to our Founder, Richard Perkins, on his retirement!!!

After 23 years, Richard Perkins, our founder and chairman is retiring from eClinical Forum. We are so grateful for all of Richard’s guidance over the years, growing the eCF from a workshop with 13 participants in Nov 1999 to now a global organization with over 2300 active participants from 50 member companies (most member companies participating from several regions around the globe) and 10 global project teams. Richard will remain as a behind-the-scenes consultant during a transition period for the rest of 2023.

We had great fun toasting Richard and telling stories at both Blue Bell and Darmstadt workshops. Thanks you Richard for all you have done for us!! We will certainly miss you!!

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

The Archiving and Decommission Team is pleased to announce the public release of three white papers:

  • "The Decommissioning of Computerised Systems Used in Clinical Trials" 
  • "Nature of a Distributed Trial Master File ‐ Practical Aspects"
  • "Data Formats Used in Clinical Trials"

These white papers were written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

Best Practice Document on Investigator’s Signature

Best Practice Document on Investigator’s Signature

The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), PR2.1"

About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor.  eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor. 

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures  the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.

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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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