Overview: ECRIN’s Quality Management System (QMS)
ECRIN has a quality management system (QMS), which is fit-for-purpose and has been adapted to its distributed infrastructure. It follows a risk and process-based approach, which is founded on the recommendations of the ISO 9001:2015 standard and the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP E6 (R2)).
It aims to coordinate and structure the organisation’s activities to meet customer and regulatory requirements, and to improve effectiveness and efficiency on an ongoing basis.
ECRIN is currently pursuing certification with ISO 9001:2015, the international standard specifying requirements for QMSs.
Scope and Application
ECRIN’s QMS covers all activities performed or delivered by the organisation and aims to ensure excellence in these activities.
ECRIN’s current activities covered by its QMS are
- Coordination of operational services to the management of multinational clinical trials in Europe
- Capacity development through participation in infrastructure development projects
- Certification of data centres that provide data management services for non-commercial controlled clinical trials
ECRIN QMS applies to the following functional areas: ECRIN core team, ECRIN in-country teams and any other functional entities, involved in ECRIN activities and services, whose roles and responsibilities are described in the ECRIN quality documents.
ECRIN (given its coordinating role and responsibility bestowed by the sponsor) must ensure that delivered services meet the sponsor’s expectations and are compliant with regulatory and quality requirements.
Quality as a Service
ECRIN offers 'quality as a service' through its data centre certification programme. ECRIN’s certification programme assesses academic data management centres (primarily in ECRIN member/observer countries) for compliance with published ECRIN data standards, using an on-site audit of the unit’s data management activities and of the IT infrastructure used to support those activities.