Date:                Thursday, February 20, 2025      Duration: One hour

Presenter:       Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM)

Dr Torsten Stemmler has been involved in GCP inspections since 2017 and has contributed to various European guidelines (e.g. Guideline on computerised systems and electronic data in clinical trials). He has a background in data management and neurobiology (specialising in psychophysics). He is currently working on GCP inspections and artificial intelligence in the EMA eSubgroup.

eClinical Solutions, and eCF member company will present an approach to AI that aims to bridge that gap – a guided user experience for automated mapping.

The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.

The eClinical Forum is “For the members and by the members” and we want to be sure that we are providing our members with the best possible support for what they do. This webinar is targetted to our "primary representatives" from each eCF member organization, however anyone interested in understanding an overview of the eClinical Forum is welcome to attend. eClinical Forum membership is per company (not individual) and participation in eCF online events, project teams, and members-only publications are available to each person in a member organization without any additional cost.

This is an eCF Birds-of-a-Feather Round-table discussion on the new landscape of AI use in clinical research document automation.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis.

The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.

This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions.  The discussion will be around:

• 100% SDV provides little value for a whole lot of work … but how do we define “critical” data such that not everything is considered critical?
• How can we implement a risk-based approach without compromising down-stream activities?

This group will develop standard approaches, processes, expectations - generate minimum standards for us to meet the opinions of global regulators.  Address the problem of generic regulations and create industry guidelines more tangible and actionable.

Team started in August 2024.  The goal is to review, prioritize and standardize the audit trail review data checks based on the eCF ATR position paper (2021) and create a list of high impact checks that can be implemented by sponsor companies and technology vendors.

The eClinical Forum is pleased to offer a free public webinar – to provide information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. 18-Sept-24: Registration Required.

The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

The "eCF Requirements" Members Release V2024 has been released.  This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for  electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.