IVD study stakeholder responsibilities
Section 5 of ISO20916 describes the main principles and responsibilities for an IVD study:
- The rights, health and safety of the subjects must be protected
- The user and other persons must be protected
- Conflicts of interest must be declared (if any)
- Regulatory and ethical requirements must be met
- Valid scientific principles are used
- An effective quality management system must be established.
The sponsor has the overall responsibility of the studies, as outlined In ISO20916 (and IVDR, preamble):
„The study sponsor shall take responsibility for ensuring that these principles are met. The sponsor shall define the roles and responsibilities of all parties including those of the sponsor, monitor, principal investigator and study team members (…).” In section 4.3. the following is added: “All parties involved in the conduct of the clinical performance study shall share the responsibility for its ethical conduct in accordance with their respective roles in the clinical performance study.”
Importantly, if a sponsor commissions external organizations, the sponsor remains obliged to monitor them and is ultimately responsible for the quality and integrity of the study (see also ISO20916 section 5.1).
