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 appropriateness of access

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