Table 3.

Proposals on measures required for registry governance, informed consent, data protection and sharing

Topic	Proposals for measures needed from stakeholders
Registry governance	Regulators and/or MAAs/MAHs to identify early in the authorisation process whether a potentially relevant registry exists and identify data elements needed, especially for post-authorisation assessments likely to be requested or imposed, and to agree on a common study protocol.
	Regulators and MAAs/MAHs to be aware of the data elements that can feasibly be collected systematically by relevant registries and to inform registries on their data needs.
	Registry holders to establish a centralised data application process (with a standard template) for stakeholders to request and obtain data.
	Communicate to patients and the public the benefits and uses of patient registry data and the value of high levels of patient inclusion in registries.
Informed consent	Registry holders to ensure clinical/treating centres confirm that registry patients have provided consent and review whether current patient consent is broad enough for possible future situations taking into account European GDPR [24].
Data sharing and data protection	Registry holders to develop a policy on data analysis and sharing summary, pseudo-anonymised, and individual patient data that aligns with national regulation and European GDPR.

GDPR General Data Protection Regulation, MAA/MAH marketing authorisation applicant/holder