WP4

The objective of this work package 4 is to create a separate legal and ethical framework for all types of registry-based research, including observational studies with real-world data and RB-RCTs.

• The legal framework will be compliant with the legislation in the Netherlands according to the Healthcare Quality, Complaints and Disputes Act (WKKGZ), the Care Quality Registration Act (Wkz), the Medical Treatment Agreement Act (WGBO), the Medical Research Involving Human Subjects Act (WMO) and the General Data Protection Regulation (GDPR; in Dutch AVG).
• A flow chart for the different types of registry-based research will be created for the legal framework. Different standard contracts are drawn up for registry-based research needed within the different work packages like clinical trial/study agreement and data/material transfer agreement.
• The legal and ethical framework will be implemented within the NHR in such a way that registry-based research within the NHR It infrastructure is possible.