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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: 21/09/2023 Export event
Birds-of-a-Feather Presentation and Discussion: Audit Trail Review Tools
Date: Thurs, 21-Sept-2023 Duration: one hour
Facilitators: Jun Zhao, Yanan Hu, Ying Huang, Boehringer-Ingelheim
Open To: Staff from eClinical Forum member companies gratis FOLLOW THIS LINK TO REGISTER: eCF Birds-of-a-Feather: Audit Trail Review Tools (eclinicalforum.org) (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )
Background: eClinical Forum Birds-of-a-Feather 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 facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
For This Topic: The facilitators will share their experiences with the Boehringer-Ingelheim audit trail review tool … how it was developed, how it is being used, and what are the benefits. They welcome and encourage an open discussion on what tools and procedures other organizations are using for audit trail review.
Note – in April 2021, the eCF, joint with SCDM, released a public white paper on this topic, that can be downloaded at Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org)
Time – We apologize for the inconvenient time in some time zones. We will be recording this session, so please also register if you would like a link to the recording.
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(09/01/2025)
eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping
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.
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members
Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)
About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.
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.