(a) The responsible party is responsible for the validation status of the system throughout its life cycle. The approach to validation of computerised systems should be based on a risk assessment that considers the intended use of the system; the purpose and importance of the data/record that are collected/generated, maintained and retained in the system; and the potential of the system to affect the well-being, rights and safety of trial participants and the reliability of trial results.
(b) Validation should demonstrate that the system conforms to the established requirements for completeness, accuracy and reliability and that its performance is consistent with its intended purpose.
(c) Systems should be appropriately validated prior to use. Subsequent changes to the system should be validated based on risk and should consider both previously collected and new data in line with change control procedures.
(d) Periodic review may be appropriate to ensure that computerised systems remain in a validated state throughout the life cycle of the system.
(e) Both standard system functionality and protocol-specific configurations and customisations, including automated data entry checks and calculations, should be validated. Interfaces between systems should also be defined and validated. Different degrees of validation may be needed for bespoke systems, systems designed to be configured or systems where no alterations are needed.
(f) Where relevant, validation procedures (until decommissioning) should cover the following: system design, system requirement, functionality testing, configuration, release, setup, installation and change control.
(g) The responsible party should ensure that the computerised systems are validated as fit for purpose for use in the trial, including those developed by other parties. They should ensure that validation documentation is maintained and retained.
(h) Validation should generally include defining the requirements and specifications for the system and their testing, along with the associated documentation, to ensure the system is fit for purpose for use in the trial, especially for critical functionality, such as randomisation, dosing and dose titrations and reductions, and collection of endpoint data.
(i) Unresolved issues, if any, should be justified and, where relevant, the risks identified from such issues should be addressed by mitigation strategies prior to and/or during the continued use of the system.