The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR” 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.

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

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

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. 

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.

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

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality. Applied Clinical Trials July/August 2013

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.

2010: Practical Considerations for Clinical Trial Sites using EHRs In support of Clinical Research, Release 1.0 January 18, 2010

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).