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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

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

Better Together

  • 2 October 2023
  • Author: Webmaster1
  • Number of views: 159
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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.

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

The Archiving and Decommission Team is pleased to announce the public release of three white papers:

  • "The Decommissioning of Computerised Systems Used in Clinical Trials" 
  • "Nature of a Distributed Trial Master File ‐ Practical Aspects"
  • "Data Formats Used in Clinical Trials"

These white papers were written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022

23 March 2023

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022"

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.

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures  the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.

Member Release: "Requirements for Electronic Data for Regulated Clinical Trials" MR2023

Member Release:  "Requirements for Electronic Data for Regulated Clinical Trials" MR2023

ABOUT THE ECF REQUIREMENTSThe eClinical Forum has updated their 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, MHRA, NMPA 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 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.

eSRA V2022 (eSource Readiness Assessment) Handbook and Assessment Questionnaire

  • 31 March 2022
  • Author: Webmaster1
  • Number of views: 42318
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eSRA V2022 (eSource Readiness Assessment) Handbook and Assessment Questionnaire

Version 2022.2 (25-May-2022; only the license agreement for those re-using in another form has been updated)

This is the ONE FILE that you need to perform an eSRA Assessment.

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Release 2022

  • 29 March 2022
  • Author: Webmaster1
  • Number of views: 8623
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Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Submission of comments on EMA’s draft “Guideline on computerised systems and electronic data in clinical trials”

2-Dec-2021

These comments are provided by a team with representatives from 13 eCF member companies and have been reviewed by the eClinical Forum members. Those on the team are from Sweden, UK, Switzerland, Belgium, Spain, Germany, Italy, United States, and Japan. They represent many hours of personal review/comment as well as 19 hours of team discussion. The larger eCF Membership had opportunity to review and comment as well.  The resulting submitted comments (59 pages) are a consensus of member opinion.

Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

An Industry Position Paper

Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback.  With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool.  This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.

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

Better Together

  • 18 March 2021
  • Author: Webmaster1
  • Number of views: 3402
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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.

Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”.  This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. The position paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.

ECF Newsletter 2020/21

Better Together

  • 23 October 2020
  • Author: Webmaster1
  • Number of views: 2303
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ECF Newsletter 2020/21

The eClinical Forum is a peer networking group run by its members for its members. Our newsletter provides important information and facts about the eClinical Forum. Read about the philosophy and objectives of the group, the eCF community and the work it has done, the teams that are active and what our members say. There is nothing quite like the eClinical Forum.

 

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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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