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.

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.

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).

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.

Submission of comments to the FDA on their Draft Guidance on Standardized Study Data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)

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

eCF comments on FDA Draft Guidance: Electronic Source Doc in Clinical Investigations

The EHRCR Functional Profile Working Group is comprised of dedicated individuals from the United States and the European Union in the following industries: pharmaceutical, biotechnology, clinical research technology vendor, healthcare technology vendor, and federal regulator.