ICH E6(R3) - Good Clinical Practice 3.16-systems: Keep a record of important computerised systems (use, functionality, interfaces, validation status, responsibility, access controls and security), implement section 4 requirements, maintain user and permission records aligned with investigator delegations, collect defect and incident reports, and assess site and clinical practice systems for fitness before use

What does 3.16-systems require?

For sponsor-deployed systems the sponsor should keep a record of the important systems used in the trial, describing use, functionality, interfaces, validation status, who manages each and the access controls and the internal and external security in place; ensure computerised system requirements (validation, audit trails, user administration, backup and recovery, IT security) and procedures and training are in place proportionate to the system's importance; keep a record of authorised users, roles and permissions; make site staff permissions match the investigator's delegations and visible to the investigator; and have a route for providers and investigators to report system defects. For systems used or deployed by sites, it should assess, during site selection and with documentation, whether systems holding source records (such as electronic health records and site files) are suitable for the purpose or have known issues that can be mitigated, assess clinical practice systems considered for trial use in proportion to data importance before use, considering security and backup, user management and audit trails. For all systems, providers and sites should be able to report incidents that could be serious noncompliance.