10/11 October 2023
The European Medicines Agency (EMA) has published a notice for sponsors of clinical trials (CTs) to highlight the requirements for the qualification and validation of computer systems used for managing CT data. This is based on recent inspection findings and takes into account implications on the integrity, reliability, robustness and acceptability of data. In line with this notice, the EMA has also updated questions 8 and 9 on EMA´s GCP Q&A website, which provide further guidance on computerised systems.
In clinical trials (CTs), large amounts of data are collected and this data is electronically recorded and processed to a growing extent. Checking Data Integrity (DI) is mandatory and is usually performed by the clinical monitor, who, in the past, preferentially reviewed only the documentation, but not the history of data entries. In addition, sponsors contract out an increasing number of tasks in CTs. During inspections of clinical trials, a growing number of deviations from GCP standards related to contractual arrangements with vendors of electronic systems and related procedures have been identified by the GCP inspectors.
In order to clarify these issues, the EMA has recently published a "Notice to sponsors on validation and qualification of computerised systems used in clinical trials". In this Notice, the EMA clearly states:
In addition the Q&As 8 and 9 on EMA´s GCP Q&A website have been updated on the basis of recent GCP inspection findings.
Q&A 8 - Qualification and Validation of Computer Systems used in CTs
Sponsors should contractually ensure
The sponsor should make sure that the vendor qualification documentation is readily available for GCP inspection. Failure to provide access to the documentation is likely to result in critical findings. A sponsor should amend any contract with vendors to ensure availability of qualification documentation. If a vendor is not willing to amend the contract, the sponsor is responsible to demonstrate that the system is validated and qualified (based on documentation provided by the vendor) or for requalification of the system.
Requalification by the Sponsor:
More information can be found online in EMA´s GCP (Good Clinical Practice) Q&As.