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 Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”

Webinar: Thursday, 16-November-2023 

eCF Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”

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.

Japanese translation of eSRA V2023

Japanese translation of eSRA V2023

Version 2023.2JP1 (18-Sep-2023)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

eClinical Forum Autumn Workshop, Kobe, Japan

November 13-14 2023

eClinical Forum Autumn Workshop, Kobe, Japan

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Kobe, Japan on November 13-14 2023.

This is an in-person workshop. There will be networking/social events on the first evenings.  Each eCF Member company in the APAC region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded. 

eClinical Forum Hybrid Workshop, Barcelona, Spain

October 4-6, 2023

  • 04/10/2023 13:00 - 06/10/2023 13:00
  • Author: Webmaster1
  • Number of views: 244
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eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

eClinical Forum Autumn Workshop, Spring House, Pennsylvania

October 24-26 2023

eClinical Forum Autumn Workshop, Spring House, Pennsylvania

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Janssen in Spring House, Pennsylvania on October 24-26 2023.

This is an in-person workshop. There will be networking/social events on both evenings.  Each eCF Member company in the Americas region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded. Information on the European workshop will be on our website soon.

eCF Views & News

August 2023

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 that participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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.

eSRA V2023 (eSource-Readiness Assessment) Handbook and Questionnaire

eSRA V2023 (eSource-Readiness Assessment) Handbook and Questionnaire

This is the ONE FILE that you need to perform an eSRA Assessment. This 2023.2 version has a correction as the previous version incorrectly had two question 26. (July 1, 2023)

Implementing eSRA - Sponsor Perspective

V2023

Implementing eSRA - Sponsor Perspective

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2023)

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

V2023

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Differences between eSRA V2023 to eSRA V2022

Differences between eSRA V2023 to eSRA V2022

What has changed?

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022

23 March 2023

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022"

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.

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eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

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

 

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Japanese translation of eSRA V2023

Japanese translation of eSRA V2023

Version 2023.2JP1 (18-Sep-2023)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

Read more
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Birds-of-a-Feather Presentation and Discussion:  Audit Trail Review Tools

Birds-of-a-Feather Presentation and Discussion:  Audit Trail Review Tools

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.

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eClinical Forum Hybrid Workshop, Barcelona, Spain

eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

Read more
5
eClinical Forum Hybrid Workshop, Barcelona, Spain

eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

Read more
6
eClinical Forum Hybrid Workshop, Barcelona, Spain

eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

Read more
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