User roles in HD4DP v2

Several user roles are possible in the HD4DP v2 application:

Local Study Lead: This role takes responsibility for the study or project within the participating healthcare organization. Often this is the head of the clinical department involved in the study or project. The Local Study Lead can:

1. make registrations in HD4DP v2
2. view all registrations made by colleagues (regardless of role) for the study or project

Local Study Associate (author): The Local Study Associate is a healthcare professional that participates in the study or project. He/she reports/records medical information towards the researcher using HD4DP v2 and thereby assumes responsibility on the correctness of the reported information. He/she is considered to be the author of the registration. For each author an author group will be created. This will be represented in the registration form. The Local Study Associate can:

1. make registrations in HD4DP v2
2. only see all registrations assigned to his/her author group, not those of other colleagues (other author groups) in the same healthcare organization participating in the same study or project

Local Study Support (co-author): A Local Study Associate can delegate registration to a Local Study Support. Often this is an administrative collaborator or staff of a department medical coding. The Local Study Associate is still considered the author of the registration; the Local Study Support is considered co-author. The Local Study Associate can view and change registrations made by Local Study Support. The Local Study Support can:

1. make registrations in HD4DP v2
2. only see all registrations assigned to his/her author group, not those of other colleagues (other author groups) in the same healthcare organization participating in the same study or project

By default, only 1 Local Study Lead is created by healthdata.be (Sciensano) for each project within each organization. This means that only 1 person can see all registrations made for that project within that organization. This policy prevents HD4DP v2 users to see personal and sensitive information from persons they do not have a therapeutic relationship with.

In case organizations create more then 1 Local Study Leads for a project within that organization, so that they all can see each others registrations, and thus personal and sensitive information from persons they do not have a therapeutic relationship with, the organizations are fully responsible and accountable for this policy deviation. Healthdata.be (Sciensano) cannot be held responsible or accountable for this policy deviation. Professionals wanting to participate in projects are kindly suggested to contact the Data Protection Officer (DPO) of their organization to consult them about this intended policy deviation.