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

White Paper Released by the Artificial Intelligence and Machine Learning Working Group

Better Together

  • 2 October 2023
  • Author: Webmaster1
  • Number of views: 738
  • 0 Comments
White Paper Released by the Artificial Intelligence and Machine Learning Working Group

The Artificial Intelligence and Machine Learning Team is pleased to announce the public release of theirwhite paper titled "AI state-of-play around clinical research"

The white paper were written by a joint task force from the eClinical Forum and Eucrof.

Artificial Intelligence and Machine Learning

  • 2 November 2022
  • Author: Webmaster1
  • Number of views: 781
  • 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: 690
  • 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. 

Public Release: Electronic Informed Consent Implementation Guide Practical Considerations Version 1.0

Better Together

  • 18 March 2021
  • Author: Webmaster1
  • Number of views: 3754
  • 0 Comments
Public Release: Electronic Informed Consent Implementation Guide  Practical Considerations  Version 1.0

The EUCROF and eClinical Forum Electronic Informed Consent (eConsent) Joint Task Force are pleased to announce the publication of the eConsent Implementation Guide (version 1). The joint task force was formed in 2019 with a view to look at some of the barriers to adoption of eConsent considering the benefits to stakeholders.

eConsent offers remote electronic options for informing and consenting trial participants of a clinical trial, this being a particularly useful capability especially during the pandemic period when site visits are reduced.

RESULTS: Investigator Site Survey

2019

  • 31 October 2019
  • Author: Webmaster
  • Number of views: 25312
  • 0 Comments
RESULTS: Investigator Site Survey

Voluntary Investigator Site Survey survey concluded with 528 responses.

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

  • 1 October 2019
  • Author: Webmaster1
  • Number of views: 7181
  • 0 Comments
Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

Audit Trail Review

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 3964
  • 0 Comments
Audit Trail Review

Best practices for meeting regulatory expectations for Audit Trail Review

Regulatory Advisory Group (REG)

  • 1 May 2018
  • Author: Webmaster1
  • Number of views: 3063
  • 0 Comments
Regulatory Advisory Group (REG)

The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites).

eSRA Maintenance

Self-Evaluating the GCP Compliance of Systems Holding Source Data

  • 1 March 2018
  • Author: Webmaster1
  • Number of views: 3354
  • 0 Comments
eSRA Maintenance

Maintaining the free eSRA (eSource-Readiness Assessment) questionnaire used by sites to self-evaluate electronic systems originating or managing data for clinical research.

White Paper, Checklist and Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

  • 22 December 2016
  • Author: Webmaster1
  • Number of views: 1664
  • 0 Comments
White Paper, Checklist and Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers (e.g. EMA Reflection Paper and ICH GCP Addendum). The eCF has engaged with regulators (including the EMA GCP IWG and FDA) and industry stakeholders in developing the documents.

Is your electronic health record system suitable for originating records that will be used in regulated clinical trials?

  • 2 March 2016
  • Author: Webmaster1
  • Number of views: 2075
  • 0 Comments
Is your electronic health record system suitable for originating records that will be used in regulated clinical trials?

Nearly 200 attendees participated in a webinar delivered by the eClinical Forum for ACRP.

The objective of the webinar was to allow attendees to:

  • Recognize the need to assess their electronic healthcare system to determine its appropriateness for originating and/or housing data that could be used in a regulated clinical research trial
  • Access a free tool to assist in assessing electronic health record systems

eCF Releases Key Documents and Tools

Partnering for Success

  • 20 November 2015
  • Author: Webmaster1
  • Number of views: 15593
  • 0 Comments
eCF Releases Key Documents and Tools

The eCF is releasing 3 documents via the eCF website “Members” area (un/pw required).  Please feel free to download them and share with other members of your company.

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Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023

The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.

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eCF APAC Autumn Workshop 2024 Announced

eCF APAC Autumn Workshop 2024 Announced

Registration is open!  Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.

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eCF APAC Autumn Workshop 2024 Announced

eCF APAC Autumn Workshop 2024 Announced

Registration is open!  Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.

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eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification

eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification

This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions.  The discussion will be around:

  • 100% SDV provides little value for a whole lot of work … but how do we define “critical” data such that not everything is considered critical?
  • How can we implement a risk-based approach without compromising down-stream activities?
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eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

Presenter:        Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)

About this topic:  The final piece of the GCP renovation puzzle, revision 3 of ICH GCP.  Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.

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