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Regulatory Considerations DMEG

The Regulatory Considerations Expert Group provides guidance on a range of topics related to regulatory frameworks in clinical data management. This includes where to find applicable regulations, how to stay informed about new and emerging requirements, and which specific areas are relevant to data management, along with what they mean in practice. The group also explores expectations around implementation, and how data management teams can best prepare for regulatory inspections.

Through this work, the Regulatory Considerations Expert Group supports the ongoing development and expertise of the wider ACDM community.

Regulatory Considerations DMEG

The Regulatory Considerations Expert Group provides guidance on a range of topics related to regulatory frameworks in clinical data management. This includes where to find applicable regulations, how to stay informed about new and emerging requirements, and which specific areas are relevant to data management, along with what they mean in practice. The group also explores expectations around implementation, and how data management teams can best prepare for regulatory inspections.

Through this work, the Regulatory Considerations Expert Group supports the ongoing development and expertise of the wider ACDM community.

Resources

The Regulatory Considerations DMEG has built, and continues to build, a collection of resources to support regulatory frameworks in clinical data management. These include the recently published FDA Q&A Guidance on Electronic Systems, Electronic Records and Electronic Signatures in Clinical Investigations: Points to Consider from the ACDM DMEG Regulatory Considerations Group.

fda

Points to Consider from DMEG.

View Here 〉

DHT

Letter to FDA on behalf of ACDM.

View Here 〉

ICH

DMEG Reflection.

View Here 〉

reg 3

‘Guideline on computerised systems and electronic data’.

View Here 〉

reg 4

ICH E6 Guideline for GPC – Update on Progress.

View Here 〉

reg 5

A paper summarising considerations.

View Here 〉

FDA 21

Suggested Implementation.

View Here 〉

Members

Silvia Perez-Torres | DMEG Chair

Associate Director, Clinical Quality Compliance | AstraZeneca

I began my career in pre-clinical research, but after completing my PhD in Neuroscience, I moved into the clinical industry, focusing mainly on Data Management. I worked in both a small CRO and later in pharma, spending nearly 12 years as a Global Data Manager Lead on phase III trials, overseeing end-to-end data activities and leading standardisation of data and processes.

More recently, I transitioned into a Quality role, supporting Biometrics functions including Data Management, Programming and Statistics. My responsibilities include providing quality guidance, managing CAPAs and risks, supporting audits and inspections, and helping teams maintain inspection readiness.

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Silvia Perez-Torres | DMEG Chair

Associate Director, Clinical Quality Compliance | AstraZeneca

I began my career in pre-clinical research, but after completing my PhD in Neuroscience, I moved into the clinical industry, focusing mainly on Data Management. I worked in both a small CRO and later in pharma, spending nearly 12 years as a Global Data Manager Lead on phase III trials, overseeing end-to-end data activities and leading standardisation of data and processes.

More recently, I transitioned into a Quality role, supporting Biometrics functions including Data Management, Programming and Statistics. My responsibilities include providing quality guidance, managing CAPAs and risks, supporting audits and inspections, and helping teams maintain inspection readiness.

OLYMPUS DIGITAL CAMERA

Interested in Joining?

The Regulatory Considerations DMEG would be delighted to invite members to our team. If you would like to be a part of the discussions, please click here.