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BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

New Date: Oct 7 2020

Event date: 07/10/2020 - 08/10/2020 Export event

BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

Birds-of-a-Feather Webinar:  The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

Date: NEW DATE: OCT 7 2020  Duration: One hour

Presenters:           Linda King, Astellas, eCF Audit Trail Review Team

Miko Pietilä, Signant Health, eCF Audit Trail Review Team

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact info@eclinicalforum.org )

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 facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

For This Topic:  

Join us for a discussion of the eCF/SCDM industry position paper on the use of audit trail review as a key tool in ensuring data integrity.   We will share our thoughts on the rationale, opportunities and challenges, along with practical implementation recommendations.  

Time: This webinar will be offered only once, however a recording will be made for those who cannot join during the live webinar.

For MEMBER registration, please follow this link: https://eclinicalforum.org/Forms/BoF-23-Sep-2020-Audit-Trail-Review ; NON-MEMBERS, please contact us: info@eclinicalforum.org

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Public Release: English Translation of V2.00 of Japan EDC Management Sheet

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures  the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.

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