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Pharma IT Insights
EMA Guideline on computerised systems and electronic data in clinical trials
By Jakob Juul Rasmussen
April 4, 2023
Pharma IT Insights
EMA Guideline on computerised systems and electronic data in clinical trials
By Jakob Juul Rasmussen
April 4, 2023
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In this Insight, Jakob Juul Rasmussen highlights the recent EMA Guideline on computerised systems and electronic data in clinical trials. Keep reading for a high-level overview of what’s included in the new guidance and to better understand the context for its adoption.
From Electronic case report forms (eCRF), to electronic patient reported outcomes (ePROs), to various wearable devices used to monitor trial participants, and ultimately to the use of artificial intelligence (AI) – the use of computerised systems in clinical research is increasing and is becoming increasingly complex
Adherence to GxP, EMA, and FDA guidelines when using computerized systems and electronic data in clinical trials is critical. Failure to comply with these guidelines could result in serious consequences such as data inaccuracies, patient harm, and regulatory non-compliance. Therefore, it is crucial for pharmaceutical companies and clinical research organizations to remain up to date on regulatory changes to ensure the integrity, accuracy, and reliability of clinical trial data.
The EMA recently released a new Guideline on computerized systems and electronic data in clinical trials which will come into effect in September of 2023. The guideline was prepared by the EMA’s Good Clinical Practice Inspectors Working Group (GCP IWG).
The new guideline replaces the previous EMA Reflection Paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical (2010) and dovetails the FDA’s guidance on Digital Technologies for Remote Data Acquisition in Clinical Investigations (2021).
It was developed based on feedback from stakeholders and experts in the field, as well as the latest technological advancements and regulatory changes. The process of developing the new guideline involved extensive consultation with the public, including a public consultation period, which helped to shape the final version of the guideline.
Ensure compliant use of computerized systems and electronic data in your clinical trials
Our expert consultants can assist you with computer system validation, clinical trial management, electronic data management, and more!
Ensure compliant use of computerized systems and electronic data in your clinical trials
Our expert consultants can assist you with computer system validation, clinical trial management, electronic data management, and more!
The new EMA guideline provides comprehensive guidance on the use of computerized systems and electronic data in clinical trials
While the guideline does not include many new expectations, it will facilitate a better understanding of GCP requirements. It also aims to ensure a more efficient conduct of clinical trials while ensuring data integrity and patient rights, safety, dignity and well-being.
The guideline covers a wide range of topics such as the selection and validation of computerized systems, the management of electronic data, data protection and security, and the maintenance of audit trails.
The main document describes definitions of key concepts as well as general requirements for computerised systems and electronic data. The guideline’s annexes go on to describe more detailed information on topics such as:
- Expectations for contracts
- Computer system validation
- User management
- IT security
- Requirements related to specific types of systems, processes and data
- A dedicated Clinical Systems annex
Overall, the new EMA guideline on computerized systems and electronic data in clinical trials provides much-needed guidance to pharmaceutical companies and clinical research organizations on the use of these systems in clinical trials. By following this guidance, companies can ensure that their clinical trial data is accurate, reliable, and compliant with regulatory requirements.
If you have any questions about the implications of the new guidance on your clinical trials, do not hesitate to reach out to our team for assistance.
Sources:
https://www.fda.gov/media/155022/download
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-electronic-data-clinical-trials_en.pdf
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-expectations-electronic-source-data-data-transcribed-electronic-data-collection_en.pdf
About the author(s)
Jakob Juul Rasmussen is the Co-Founder and Managing Director of Pharma IT. He has 20 years of experience managing IT projects within the Pharma, Finance, and Public sectors.
