Guideline On Computerized Systems and Electronic Data in Clinical Trials

17-Dec-2024

Clinical research is increasingly using computerized methods. From electronic case report forms (eCRF) and electronic patient-reported outcomes (ePROs) to various wearable devices that continuously monitor trial participants for clinically relevant parameters, and finally to the use of artificial intelligence (AI), the complexity of such systems has rapidly evolved in recent years. In order to ensure the quality and reliability of trial data as well as the rights, dignity, safety, and well-being of trial participants, it is necessary to guide all stakeholders involved in clinical trials that reflect these changes in data types and trial types regarding the use of computerized systems and the collection of electronic data. This will help to ensure full FDA compliance for Computer Systems.

The Guideline on Computerized Systems and Electronic Data in Clinical Trials is a guiding light for handling electronic data in clinical trials to ensure 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. It must maintain its integrity throughout its life cycle, which maintains FDA compliance for computer systems. This Computerized 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

Compliance and Implementation

This guideline explains several broadly applicable concepts, such as the ALCOA++ principles, with a focus on the traceability of data that can be ascribed to the people who create it. It must retain its integrity throughout its life cycle in order to meet FDA requirements for computer systems. This Computerized Systems and Electronic Data in Clinical Trials guideline highlights the need to keep an audit trail that securely records the production and subsequent alterations of all electronic data. This guideline establishes the rules for validation, user management, security, and electronic data, allowing sponsors to demonstrate that their data is secure and correct to regulatory agencies and stakeholders

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 the 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.
• Any changes to the data should be documented as part of the metadata.
• Data integrity is achieved when data are collected, accessed, and maintained securely to fulfill the ALCOA++ principles.
• Documentation (including information within computerized systems used as process tools for validation activities) should be maintained to demonstrate that the system is kept validated. Such documentation should be available for both the validation of the computerized system and for the validation of the trial-specific configuration or customization

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.