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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

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

Requirements for Regulated Electronic Data in Clinical Trials and the Site eSource-Readiness Assessment

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021. Even in 2024, the content is still relevant.

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: 1992
  • 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

Site Survey Presentation - DIA Clinical Forum Lisbon 13 Oct10

  • 3 December 2015
  • Author: Webmaster1
  • Number of views: 1959
  • 0 Comments
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.

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: 2040
  • 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.

eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data for Clinical Trials (ACDM UK 10Mar14)

  • 3 December 2015
  • Author: Webmaster1
  • Number of views: 1959
  • 0 Comments
eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data for Clinical Trials (ACDM UK 10Mar14)

Investigators are frequently asked to complete sponsor-specific assessments of their EHR systems to enable sponsors to evaluate clinical trial data that will be sourced from these systems.

Investigator Site eSource-Readiness Assessment Tool

  • 9 August 2013
  • Author: Webmaster1
  • Number of views: 1774
  • 0 Comments
Investigator Site eSource-Readiness Assessment Tool

The eClinical Forum eSource Sub-team is working on a common assessment tool to determine Investigator Site eSource-Readiness.

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

  • 12 March 2013
  • Author: Webmaster1
  • Number of views: 1488
  • 0 Comments
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.

Risk Based Approaches: Best Practices for Ensuring Clinical Data Quality WEBINAR Slides Feb 2013

  • 22 February 2013
  • Author: Webmaster1
  • Number of views: 1211
  • 0 Comments
Risk Based Approaches: Best Practices for Ensuring Clinical Data Quality WEBINAR Slides Feb 2013

Webinar slides discussing the work of the eClinical Forum "Risk Based Monitoring" Subteam. Public webinar on 22-Feb-2013. 

Leveraging EHR Data to Improve Clinical Research - Informa Brussels 25May11

  • 8 June 2011
  • Author: Webmaster1
  • Number of views: 1091
  • 0 Comments
Leveraging EHR Data to Improve Clinical Research - Informa Brussels 25May11

Leveraging EHR Data to Improve Clinical Research - Informa Brussels 25May11

2004: EDC Performance Metrics - Full Report

  • 22 June 2004
  • Author: Webmaster1
  • Number of views: 1381
  • 0 Comments
2004: EDC Performance Metrics - Full Report

The eClinical Forum's 2004 Metric Survey of companies involved in conducting EDC trials assesses the feasibility of establishing standard EDC performance metrics.

2003: eCF Presentation to EMEA GCP Inspectors on EDC

  • 22 October 2003
  • Author: Webmaster1
  • Number of views: 1304
  • 0 Comments
2003:  eCF Presentation to EMEA GCP Inspectors on EDC

Please download to review this presentation.

2003: Regulatory Environment for Electronic Data Capture

  • 12 February 2003
  • Author: Webmaster1
  • Number of views: 1254
  • 0 Comments
2003: Regulatory Environment for Electronic Data Capture

Please download to review this report.

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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 Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

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eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023"

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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