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Focus on Regulation

EMA provides guidance on the sponsor’s role in validating electronic systems used in clinical trials

The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline[1] to clarify the level of validation/qualification that needs to be performed by a sponsor in a clinical trial setting when using an electronic system previously qualified by a vendor. The updated Guideline, issued in the form of a Q&A document, provides that it is the sponsor who is ultimately responsible for validating clinical trial processes that are supported by electronic systems.

In clinical trials settings, the use of electronic systems has proven to be more the standard than the exception. The systems are used for different purposes including data collection, data management, safety data management and evaluation, treatment allocations. A considerable number of electronic case report forms and applications for instance collection of patient related outcome or clinical outcome assessment are provided by, or purchased from, vendors and customised to varying degrees. As a result, the EMA explains that the GCP inspectors receive an increasing number of questions with regard to this topic. In addition, the EMA calls attention to the fact that deviations were given during GCP inspections, regarding the level of validation/qualification needed to be performed by a sponsor when using a system that has already been validated by the supplier.

The updated Guideline is intended to address the situation in which a sponsor uses an electronic system in the manner intended by a vendor. This includes the built-in possibilities for configuration. The electronic system may be a system validated by the supplier, but installed by the sponsor, or a system provided as software-as-a-service (SaaS or cloud solution). However the updated Guideline provides that different requirements will apply for the validation or qualification of electronic systems where the sponsor changes or adds functionalities to the system.

The updated Guideline clarifies that the sponsor is ultimately responsible for validation of the clinical trial processes which is supported by electronic systems. The updated Guideline further specifies that the approach to validation should be based on a risk assessment. This risk assessment must take into consideration the intended use of the system and the potential of the system to affect human subject protection and the reliability of the trial results. It should be justified by the sponsor and documented. The sponsor may rely on qualification documentation provided by the vendor if the qualification activities performed by the vendor have been assessed as adequate. However, the sponsor may also need to perform additional qualification/validation activities based on a documented risk assessment.

The updated Guideline includes a non-exhaustive list of conditions under which the sponsor can use the vendor’s qualification documentation. This includes, for example, that the sponsor has a thorough knowledge about the vendor’s quality system and qualification activities, which will usually be obtained through an in-depth assessment/audit.

According to the updated Guideline, sponsors and vendors should be aware that GCP inspectors could inspect documentation regarding the qualification process. They inspectors may also inspect any other relevant documentation on the e-system maintained at a sponsor level, as well as on the vendor level if the electronic systems are used for generating/handling relevant clinical data or maintain control and oversight of clinical trial processes. This documentation is considered as essential by GCP inspectors and is likely to be requested during GCP inspections. This holds true regardless of whether or not the sponsor contracted out activities related to electronic systems or decided to consider the assessment of the vendor’s systems/processes/documentation as an audit. The updated Guideline provides that GCP inspectors do not consider the documentation or the report of these activities as an audit report.

 

 

 

[1] European Medicines Agency, Q&A: Good clinical practice (GCP), available at this link.