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

"When should audit trail begin?" 17 June 20210

"When should audit trail begin?"

Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?"  It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

We welcome feedback! Please send to: REG@eclinicalforum.org 

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

ACT Article on eCF Risk Based Monitoring Approaches and Best Practices 15 December 20150

ACT Article on eCF Risk Based Monitoring Approaches and Best Practices

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