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

Three white papers released by the Archiving and the Decommissioning Team

Three white papers released by the 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.

eCF Views & News

April 2023

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.

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.

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.

REGISTRATION IS OPEN: eClinical Forum Hybrid Workshop, Darmstadt, Germany June 14-16, 2023

Darmstadt, Germany

  • 14/06/2023 - 16/06/2023
  • Author: Webmaster1
  • Number of views: 206
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REGISTRATION IS OPEN: eClinical Forum Hybrid Workshop, Darmstadt, Germany June 14-16, 2023

We are pleased to announce that registration is now open for our next European Workshop in Darmstadt Germany on June 14-16 hosted by eClinical Forum.

This hybrid workshop is available for face-to-face or remote participation.

READ MORE to download Agenda

REGISTER NOW

Artificial Intelligence and Machine Learning

  • 2 November 2022
  • Author: Webmaster1
  • Number of views: 254
  • 0 Comments
Artificial Intelligence and Machine Learning

The joint Working Group on AI/ML by eClinical Forum and EUCROF is monitoring the evolution of AI/ML technologies in the Life Sciences domain and addressing relevant topics that are of major interest for clinical research.

Decentralised Clinical Trials

  • 2 November 2022
  • Author: Webmaster1
  • Number of views: 156
  • 0 Comments
Decentralised Clinical Trials

The DCT Working Group is a joint effort between eClinical Forum and EUCROF. The team's objectives are to define DCT terms and to develop position papers and roadmaps on DCT solutions that simplify patient and site experiences. 

e-Investigator Site File Questionnaire (eISFQ)

e-Investigator Site File Questionnaire (eISFQ)

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

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. 

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eClinical Forum In-Person and Remote Workshop, Blue Bell, PA

eClinical Forum In-Person and Remote Workshop, Blue Bell, PA

We are pleased to announce our next Americas Workshop in Blue Bell, PA USA on May 15-17 kindly hosted by Signant Health.

This workshop will be available for face-to-face and remote participation.

We hope you can join us!

Read more
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eClinical Forum In-Person and Remote Workshop, Blue Bell, PA

eClinical Forum In-Person and Remote Workshop, Blue Bell, PA

We are pleased to announce our next Americas Workshop in Blue Bell, PA USA on May 15-17 kindly hosted by Signant Health.

This workshop will be available for face-to-face and remote participation.

We hope you can join us!

Read more
17
eClinical Forum In-Person and Remote Workshop, Blue Bell, PA

eClinical Forum In-Person and Remote Workshop, Blue Bell, PA

We are pleased to announce our next Americas Workshop in Blue Bell, PA USA on May 15-17 kindly hosted by Signant Health.

This workshop will be available for face-to-face and remote participation.

We hope you can join us!

Read more
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