Table 2.

RACI (Responsible/Accountable/Consulted/Informed) Chart for the role definitions of the relevant stakeholder/collaborator groups for the PICO (Population/Intervention/Comparator/Outcomes) categories in the EU HTA procedure as defined in the EU HTA Regulation.

	Patients	Clinicians	Regulators§	HTDs	EU – HTA
Population	C	C (important)	C (optional)	I (evt C)	R*
Intervention	I (optional)	I	n/a	A/R	I
Comparator	C	C (important)	C (optional)	I (evt C)	R*
Outcomes	C (Important)	C (important)	C (optional)	I (evt C)	R*

Note: *: HTA bodies are consulted (C) during the development phase; accountability (A) resides with national HTA bodies. §: For the regulatory approval process, regulators are A/R throughout the process which is creating the frame for EU HTA to operate. evt: eventually.