9/08/2020
On April 7, 2020, the European Medicines Agency (EMA) released a Notice to sponsors on validation and qualification of computerized systems used in clinical trials. This guidance is applicable for clinical trials conducted in the EU and clarifies that even though a sponsor may delegate all or part of clinical trial activities out to a company, the ultimate responsibility for validation of software tools or electronic systems remains with the sponsor. This guidance also clarifies that most vendors focus on system security of the participant’s personal data, but they lack a focus on how an electronic system used in a clinical trial must comply with Good Clinical Practice (GCP) and the documentation principles of ALCOA+.
Recent inspection findings and their implications regarding data integrity have influenced this new guidance to highlight the requirements for sponsors and vendors in providing computerized services in clinical trial management. GCP sponsor responsibilities that are linked to the basis of the new guidance are:
Documentation of computer system qualification and validation activities
Access to computer system qualification and validation documentation
Sufficient contractual arrangements between sponsor and vendors
This guidance supports and enhances components of ICH E6(R2) including the GCP requirements for qualification and validation of computerized systems (Sections 1.65 and 5.5.3), recording, handling and storage of clinical data (Section 2.10) and also quality control (Section 2.13).
It should be read in conjunction with Q8 and Q9 from the GCP Question and Answers section published on the EMA website. Possible pitfalls associated with using vendor contracts for electronic systems are mentioned:
All services delegated to the vendor must be clearly documented
The sponsor must ensure the vendor understands the requirements for the system to comply with quality systems
The sponsor should have access to perform audits at the vendor’s site and the vendor can be subject to inspections by regulatory authorities
The guidance aims to identify specific quality systems elements to support the use of electronic systems regarding sponsor, site and IRB/EC regulatory responsibilities in order to ultimately protect clinical trial data and subjects in the context of electronic systems.
-The Clinical Pathways Team
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