LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.


ECF Teams and Projects

Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 26 February 20210

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.

AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY 02 October 20200

AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY

eClinical Forum Audit Trail Review Team with SCDM Innovation Committee are pleased to announce the release of their Industry Position Paper.

In clinical research, data integrity is paramount, and the importance of the right policies, procedures, responsibilities, and governance cannot be overstated. 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. It contains practical implementation guidance, covering the people, processes and technology needed to execute ATRs effectively. The authors also take a deep dive into the technical aspects of what constitutes an audit trail, and how collecting and preparing audit trail data is fundamental to successful ATR capability.

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA 01 October 20190

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

Applied Clinical Trials publishes article on eCF Requirements 15 July 20190

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 20160

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? 02 March 20160

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 03 December 20150

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 20130

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 20130

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.

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