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

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.

Submission of comments to the FDA on their Draft Guidance on Standardized Study Data 23 April 20120

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

eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials) 06 February 20120

eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)

eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)

Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research 08 June 20110

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

12345