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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
Event date: 20/02/2025 Export event
eCF Webinar: Audit Trail Review – Is your Audit Trail fit for purpose?
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.
About this topic: We will be discussing …
- Data Log
o Ensure data traceability
o Demonstrate data integrity
o Meet regulatory requirements
- Access Log
o Ensure appropriateness of access
o Ensure data security
o Demonstrate protocol compliance (e.g. blinding)
- Export Log
o Demonstrate data flow
o Ensure compliance with statistical analysis
Time: We apologize for the inconvenient time for our members in the Asia Pacific time zones. We will be recording the session, so if you are unable to attend, please register to receive the recording.
Open To: All employees of eClinical Forum member companies (gratis). Please feel free to forward this invitation within your organization.
Background: eClinical Forum webinar sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The eClinical Forum does not endorse any particular technology, system or platform.
eCF Members Registration: Register by using this link: eCF Webinar: Audit Trail Review
Non-eCF Members: To inquire about membership, please see the tab on this website "Membership" and/or contact info@eclinicalforum.org
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eCF Spring 2025 Workshops Announced
We are pleased to announce our 2025 Spring Workshops.
These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.
April 8-10: Bangalore, India (kindly hosted by i2e)
April 29-May 1: King-of-Prussia, PA, USA (kindly hosted by CSL Behring)
May 13-15: Walton Oaks, Surrey, UK (kindly hosted by Pfizer)
(29/04/2025 - 01/05/2025)
eCF “Birds of a Feather” Webinar: Patient Voices: Transforming Healthcare Innovation
We will have a discussion with Savvy Cooperative on how engaging patient experiences can lead to better clinical, regulatory, and commercial outcomes.