Computerised Systems and Electronic Data in Clinical Trials: New Guidelines and How to Reduce Risk

Computerised Systems and Electronic Data in Clinical Trials play critical roles in data management, analysis, and reporting. And the systems used in clinical trials have evolved rapidly in recent years from electronic Case Report Forms (eCRF) and electronic Patient Reported Outcomes (ePROs) to various wearable devices and cutting-edge technologies such as artificial intelligence (AI).

These innovations have made the system increasingly complex, ultimately leading to the need for new guidelines and rules to ensure the integrity, reliability, and regulatory compliance of these systems.

The European Medicines Agency (EMA) is tasked with harmonizing the work of the National Health and Regulatory Authorities of EU member states, a goal that entails releasing directives and guidelines. EMA has released a new Guideline on Computerised Systems and Electronic Data in Clinical Trials in March 2023 replacing the Reflection paper published in 2010.

Why is this Computerised Systems and Electronic Data in Clinical Trials guideline important?

The Guideline on Computerised Systems and Electronic Data in Clinical Trials is a guiding light for handling electronic data in clinical trials for ensuring compliance and top-notch practices which helps sponsors, investigators and all involved parties to align with the current legislation (Regulation (EU) No 536/2014, Directive 2001/20/EC and Directive 2005/28/EC), and ICH E6 R2 (EMA/CHMP /ICH/135 /1995 Revision 2) for Good Clinical Practice (GCP).

This guideline describes some generally applicable principles such as ALCOA++ principles, focusing on the traceability of data that can be attributed to the individuals who generate it and must maintain its integrity throughout its life cycle.

This Computerised Systems and Electronic Data in Clinical Trials guideline emphasizes the importance of maintaining an audit trail, that should securely record the original creation and subsequent modifications of all electronic data. This guideline lays down the law on validation,  user management,  security and electronic data  where sponsors can  establish that their data is secure and accurate for the regulatory authorities and stakeholders.

Further reducing risk

Cloud Data Management Solutions offers a suite of services connected to computerised systems in clinical trials. These services can vary from Infrastructure as a Service (IaaS), Platform as a Service (PaaS) or  Software as a Service (SaaS).

This opens the door for a risk-based approach to mitigate the specific challenges of cloud computing, as many services are managed less visibly by the cloud provider.

To ensure that data is maintained in a secure manner, the Computerised Systems and Electronic Data in Clinical Trials guideline describes the process of backup, data migration, archiving procedures, and decommissioning so that nothing is compromised during migration and that data is archived in a read-only state and made available as dynamic files, respectively.

Six annexes are covered within the guideline, providing additional guidance on:

• agreements,
• computerized systems validation,
• user management,
• security measures,
• electronic signatures, and
• archiving.

Compliance with the guideline by pharmaceutical companies and clinical research organizations (CROs) when using Computerised Systems and Electronic Data in Clinical Trials is critical to ensure the integrity, accuracy, and reliability of all clinical trial data.

Compliance and Implementation

Organizations should carefully review the Computerised Systems and Electronic Data in Clinical Trials guideline to ensure that all systems meet the requirements outlined and potentially leverage technology to improve efficiency and productivity in clinical trials by streamlining the processes. This will help ensure:

• Systems are compliant with regulatory requirements to ensure data security, audit trails, and system validation.
• The system validation process is implemented prior to use of systems to ensure their accuracy and reliability.
• Systems can capture high-quality data and apply best practices to accomplish data
• Regular reviews and updates, data backup, and disaster recovery are in place and systems are updated continuously to meet compliance and improve functionality.

The EMA Guideline on Computerized Systems and Electronic Data Management in Clinical Trials establishes a comprehensive framework for the proper management of electronic data and systems throughout the clinical trial lifecycle that helps to ensure the integrity and reliability of clinical trial data for Sponsors, CROs, and other stakeholders.

A good understanding of this guideline and strategic approach is critical. Identifying the procedural or technical changes required for your organization to implement per the new EMA guidelines can help to advance the field of clinical research and ultimately lead to better patient outcomes.

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Authored by: Poornima Kolla, Quality and Compliance Associate, Quality and Compliance.