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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

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

  • 1 October 2019
  • Author: Webmaster1
  • Number of views: 7315
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Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .  July 8, 2019

The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) 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

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: 1749
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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: 2169
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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

2001 to 2009: Investigational Site Perspectives on Clinical Trial Information Systems - Sep 2012

  • 3 December 2015
  • Author: Webmaster1
  • Number of views: 1340
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2001 to 2009: Investigational Site Perspectives on Clinical Trial Information Systems - Sep 2012

Abstract

In 2001, a survey was conducted by the eClinical Forum to explore the experience, needs, views and issues of investigational site staff with respect to Electronic Data Capture (EDC).

Risk-Based Approaches - Best practices for ensuring clinical data quality

  • 10 September 2013
  • Author: Webmaster1
  • Number of views: 1363
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Risk-Based Approaches - Best practices for ensuring clinical data quality

Companies engaged in commercial clinical research have, since the introduction of formalized good clinical practices (GCP), adopted highly defensive practices around the monitoring of clinical trials.

EHR4CR - A new technological platform enabling the re-use of data from electronic health records

  • 12 March 2013
  • Author: Webmaster1
  • Number of views: 1656
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EHR4CR - A new technological platform enabling the re-use of data from electronic health records

CASE STUDY EHR4CR - A new technological platform enabling the re-use of data from electronic health records.

Submission of comments to the FDA on their Draft Guidance on Standardized Study Data

  • 23 April 2012
  • Author: Webmaster1
  • Number of views: 1062
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Submission of comments to the FDA on their Draft Guidance on Standardized Study Data

Submission of comments to the FDA on their Draft Guidance on Standardized Study Data

eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)

  • 6 February 2012
  • Author: Webmaster1
  • Number of views: 1088
  • 0 Comments
eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)

eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)

Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research

  • 8 June 2011
  • Author: Webmaster1
  • Number of views: 1275
  • 0 Comments
Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research

Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research

eCF comments on FDA Draft Guidance: Electronic Source Doc in Clinical Investigations

  • 5 April 2011
  • Author: Webmaster1
  • Number of views: 1199
  • 0 Comments
eCF comments on FDA Draft Guidance: Electronic Source Doc in Clinical Investigations

eCF comments on FDA Draft Guidance: Electronic Source Doc in Clinical Investigations

2010: EuroRec Electronic Health Records for Clinical Research, Functional Profile, Version 1.0, January 2010

  • 16 July 2010
  • Author: Webmaster1
  • Number of views: 1278
  • 0 Comments
2010: EuroRec Electronic Health Records for Clinical Research, Functional Profile, Version 1.0, January 2010

The EHRCR Functional Profile Working Group is comprised of dedicated individuals from the United States and the European Union in the following industries: pharmaceutical, biotechnology, clinical research technology vendor, healthcare technology vendor, and federal regulator.

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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.

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eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

eClinical Solutions, and eCF member company will present an approach to AI that aims to bridge that gap – a guided user experience for automated mapping.

The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.

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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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eCF Webinar:  Audit Trail Review – Is your Audit Trail fit for purpose?

eCF Webinar:  Audit Trail Review – Is your Audit Trail fit for purpose?

Date:                Thursday, February 20, 2025      Duration: One hour

Presenter:       Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM)

Dr Torsten Stemmler has been involved in GCP inspections since 2017 and has contributed to various European guidelines (e.g. Guideline on computerised systems and electronic data in clinical trials). He has a background in data management and neurobiology (specialising in psychophysics). He is currently working on GCP inspections and artificial intelligence in the EMA eSubgroup.

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