Last April, the EMA issued a notice to sponsors on the validation and qualification of computerised systems used in clinical trials.
As the opening point of the document, the importance of the integrity, reliability, and robustness of data generated in clinical trials is highlighted for regulatory authorities. It is also noted that the majority of clinical trial data is currently collected through electronic data capture tools, such as electronic case report forms (eCRF) and electronic patient-reported outcomes (ePRO).
This is why the following message is reinforced: "The integrity, reliability, and robustness of the data will depend on the design and validation status of the computerised systems used. If the validation status of a computerised system is not documented and therefore not demonstrated, this is likely to pose a risk to the integrity, reliability, and robustness of the data, which, depending on the importance of the affected data, could lead GCP inspectors to recommend to the Committee for Medicinal Products for Human Use (CHMP) that such data not be used in the context of a marketing authorisation application."
It is worth noting the terminology used in the document. The term "qualification" is used to describe the verification of system functionality. The term "validation" is used to describe the process of establishing and documenting that the specified requirements of a computer system can be consistently met from its design through to its decommissioning or transition to a new system; that is, that it functions according to the specifications and standard operating procedures (SOPs) defined by a suitably trained user.
The document also underlines the direct responsibility of the sponsor: regardless of whether a sponsor delegates all or part of the clinical trial-related activities to an individual or an organisation, the ultimate responsibility with respect to the conduct of the clinical trial — in particular with regard to the safety of subjects and the integrity, reliability, and robustness of the data generated in the clinical trial — lies with the sponsor.
It also states that the sponsor may rely on qualification documentation provided by the vendor, provided that the qualification activities carried out by the vendor have been deemed adequate.
Regarding collaboration with vendors, it is established that clear, written agreements must exist specifying the arrangements with respect to qualification and validation. Access for GCP inspectors to vendor documentation must be ensured, where applicable.
This notice reinforces the importance of data integrity and the focus on data governance activities, beginning with the validation of computerised systems and continuing with the maintenance of the state of control.