One notable aspect of the guideline is the inclusion of previously overlooked computerized systems that now require validation. These systems include portals, trial recruitment databases, cloud solutions, and more, highlighting their importance in maintaining Good Practice (GxP) standards.
A significant addition to the guideline is the introduction of ALCOA++ principles. Building upon the established ALCOA+ principles, the "+ +" signifies the added element of traceability. This means that data must be traceable throughout its life cycle, with any changes properly documented as metadata, including an audit trail.
Data retention and database decommissioning are also covered in the guideline. EU regulations require that the database be available for 25 years, and even after the system is locked, the flat files should remain accessible for an additional 25 years during archiving.
The guideline highlights the importance of clearly defining roles and responsibilities in clinical trials. Investigators, their institutions, laboratories, technical departments, clinics, and sponsors all have specific responsibilities regarding the handling and management of data within computerized systems. Sponsors may directly manage these systems or utilize service providers to collect and store data on their behalf.
Regarding audit trails, the guideline emphasizes their importance in documenting the original creation and subsequent modifications of electronic data. The audit trail should be secure, computer-generated, and timestamped. Procedures for risk-based trial-specific audit trail reviews should be in place, and data review should focus on critical data. Both manual and technological review methods can be employed to facilitate the review of large datasets.
The guideline also includes six annexes covering various aspects, such as agreements, computerized systems validation, user management, security measures, additional considerations for specific systems (e.g., IRT systems, electronic informed consent), and clinical systems (e.g., user management, trial-specific data acquisition tools, archiving).
Annex 6 added in the final version addresses the implementation of clinical systems in trial sites. This added document, aims to standardize the use of computerized systems in facilities such as hospitals, which may be unfamiliar with their usage. By promoting data integrity, this annex seeks to ensure consistent practices across all clinical trials.
Clear responsibilities have been defined for investigators (researchers) and sponsors (pharmaceutical companies or their authorized service providers) regarding the management, operation, and recording of data within computerized systems. Investigators are also expected to review and audit their own data for any changes, further reinforcing data integrity.
The release of this guideline represents a notable advancement in the standardization of computerized systems and the preservation of data integrity within clinical trials. Successfully implementing these guidelines will enhance transparency, reliability, and adherence to regulatory requirements in the realm of clinical research.
