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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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Japanese Translation: eSRA Handbook and Assessment Forms V2025.2
の日本語版2025.2JP1が2025年6月30日にリリースされました。
eCF "BoF" Round table: "A Chat about eCOA"
eClinical Forum Birds-of-a-Feather round-table webinars 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.