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.

The joint Working Group on AI/ML by eClinical Forum and EUCROF is monitoring the evolution of AI/ML technologies in the Life Sciences domain and addressing relevant topics that are of major interest for clinical research.

The DCT Working Group is a joint effort between eClinical Forum and EUCROF. The team's objectives are to define DCT terms and to develop position papers and roadmaps on DCT solutions that simplify patient and site experiences. 

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.

Voluntary Investigator Site Survey survey concluded with 528 responses.

Best practices for meeting regulatory expectations for Audit Trail Review

The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites).

Maintaining the free eSRA (eSource-Readiness Assessment) questionnaire used by sites to self-evaluate electronic systems originating or managing data for clinical research.

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

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).