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

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.

eCF Releases Key Documents and Tools

Partnering for Success

  • 20 November 2015
  • Author: Webmaster1
  • Number of views: 15498
  • 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.

Regulatory Expert Group (REG)

Maintaining group expertise in regulatory environment

  • 5 May 2015
  • Author: Webmaster1
  • Number of views: 2626
  • 0 Comments
Regulatory Expert Group (REG)

Maintaining ECF expertise in the regulatory environment and trends

EDC Hosting - ENDED

  • 26 November 2013
  • Author: Webmaster1
  • Number of views: 2151
  • 0 Comments
EDC Hosting - ENDED

Best practices for data transcribed to electronic data collection tools

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

  • 10 September 2013
  • Author: Webmaster1
  • Number of views: 1187
  • 0 Comments
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.

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.

Information on the eCF Autumn 2013 Meetings

  • 9 August 2013
  • Author: Webmaster1
  • Number of views: 1583
  • 0 Comments
Information on the eCF Autumn 2013 Meetings

The eClinical Forum holds several workshops/year, typically hosted at one of the member sites.  Our Autumn 2013 European meeting is being hosted by ICON at their offices in Dublin, Ireland on Sept 18-20.

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. 

Risk-Based monitoring - ENDED

  • 15 May 2012
  • Author: Webmaster1
  • Number of views: 2126
  • 0 Comments
Risk-Based monitoring - ENDED

Best practices for ensuring clinical data quality

Submission of comments to the FDA on their Draft Guidance on Standardized Study Data

  • 23 April 2012
  • Author: Webmaster1
  • Number of views: 1014
  • 0 Comments
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

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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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