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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

Site Survey Presentation - DIA Clinical Forum Lisbon 13 Oct10

  • 3 December 2015
  • Author: Webmaster1
  • Number of views: 2053
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Site Survey Presentation - DIA Clinical Forum Lisbon 13 Oct10

Revisiting the eClinical Paradigm

Investigational Site Perspectives on Clinical Trial Information Systems

 

As the healthcare and pharmaceutical technology spheres move closer together at the clinical research interface, the eClinical paradigm needs to be revisited in order to leverage emerging political, cultural, procedural and technological opportunities. Understanding investigational site experiences with today’s clinical trial technologies and their perspectives on future requirements is critical to delivery of improved eClinical solutions.

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

  • 3 December 2015
  • Author: Webmaster1
  • Number of views: 1294
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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).

EHR4CR: An Innovative Platform and Business Model for Re-Use of EHR for Clinical Research (ACDM UK 10Mar14)

  • 3 December 2015
  • Author: Webmaster1
  • Number of views: 2122
  • 0 Comments
EHR4CR: An Innovative Platform and Business Model for Re-Use of EHR for Clinical Research (ACDM UK 10Mar14)

Improved access to patient data is key to managing bottlenecks in clinical research. The presentation gives an overview of one of the largest public-private partnerships aimed at providing adaptable, reusable and scalable solutions for re-using patient level data from Electronic Health Record systems for Clinical Research.

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

  • 10 September 2013
  • Author: Webmaster1
  • Number of views: 1242
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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.

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

  • 8 June 2011
  • Author: Webmaster1
  • Number of views: 1220
  • 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

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

  • 16 July 2010
  • Author: Webmaster1
  • Number of views: 1207
  • 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.

2009: Revisiting the eClinical Paradigm - Investigational Site Perspectives on Clinical Trial Information Systems, DIA Nice Oct09

  • 16 May 2009
  • Author: Webmaster1
  • Number of views: 1083
  • 0 Comments
2009: Revisiting the eClinical Paradigm - Investigational Site Perspectives on Clinical Trial Information Systems, DIA Nice Oct09

As the healthcare and pharmaceutical technology spheres move closer together at the clinical research interface, the eClinical paradigm needs to be revisited in order to leverage emerging political, cultural, procedural and technological opportunities. Understanding investigational site experiences with today’s clinical trial technologies and their perspectives on future requirements is critical to delivery of improved eClinical solutions

2009: EHRCR User Requirements Addendum, Draft 2, 16 April 2009

  • 16 April 2009
  • Author: Webmaster1
  • Number of views: 1169
  • 0 Comments
2009: EHRCR User Requirements Addendum, Draft 2, 16 April 2009

2009: EHRCR User Requirements Addendum, Draft 2, 16 April 2009

2009: HL7 EHR Clinical Research Functional Profile, Release 1

  • 1 January 2009
  • Author: Webmaster1
  • Number of views: 1160
  • 0 Comments
2009: HL7 EHR Clinical Research Functional Profile, Release 1

2009: HL7 EHR Clinical Research Functional Profile, Release 1

2008: Considerations for Implementation of ePRO in Clinical Studies - V2

  • 1 December 2008
  • Author: Webmaster1
  • Number of views: 1337
  • 0 Comments
2008: Considerations for Implementation of ePRO in Clinical Studies - V2

Considerations for Implementation of Electronic Patient Reported Outcomes (ePRO) in Clinical Studies 

A Guide to the Options, Issues, Best Practices and Learning Experiences

2008, April: EMEA eSource Draft -- Comments from eClinical Forum

  • 1 April 2008
  • Author: Webmaster1
  • Number of views: 1308
  • 0 Comments
2008, April:  EMEA eSource Draft -- Comments from eClinical Forum

Please download to review these comments.

2007: Electronic Health Records for Clinical Research Project Description

  • 1 February 2007
  • Author: Webmaster1
  • Number of views: 1228
  • 0 Comments
2007: Electronic Health Records for Clinical Research Project Description

Please download to review this document.

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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.

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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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2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The "eCF Requirements" Members Release V2024 has been released.  This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for  electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.

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Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

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eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML

eCF Birds-of-a-Feather Webinar:  Protocol Optimization using AI/ML

We will be discussing the transformative potential of Artificial Intelligence (AI) and Generative AI in clinical development.

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