Regulatory Considerations Data Management Expert Group (DMEG)
What is a DMEG?
A Data Management Expert Group (DMEG) is a specialised forum established by the Association for Clinical Data Management (ACDM) to bring together professionals with deep expertise in specific areas of clinical data management. These groups aim to foster collaboration, share best practices, and drive forward the industry’s standards and innovations. Each DMEG focuses on a unique aspect of data management, supporting the ACDM community by providing insights, organising events, and producing thought leadership content.
Regulatory Considerations DMEG
The Regulatory Considerations Expert Group looks at providing guidance information on a number of areas surrounding regulations. These include, where to find regulations and being aware of any new ones. Which parts are relevant to data management and what they mean. The expectations and recommendations on implementation and what data management needs to be prepared for in readiness for inspection.The Regulatory Considerations group aims to further the development and skill-set of our wider ACDM community and would be delighted to invite members to our team.
Regulatory Considerations Expert Group outputs
ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”
Date: April 5, 2022
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ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management
Date: April 5, 2022
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EMA submission of comments on ‘Guideline on computerised systems and electronic data’
Date: January 27, 2022
ICH E6 Guideline for Good Clinical Practice (GPC) – Update on Progress
Date: June 8, 2021
FDA 21 CFR Part 11 Subpart B Electronic Records Requirements & Annex 11 Computerised Systems – Suggested Implementation
Date: May 13, 2021
Regulatory Considerations DMEG Chair
Silvia Perez Torres (Chair)
Associate Director, Clinical Quality Compliance | AstraZeneca