User roles in HD4DP v2

Last updated: 2024-01-07 12:34

Each healthcare organization has at least one Access Manager who oversees the access rights to the applications of their own organization and manages them in the HD Entity Access Management (EAM) system. In this process, access requests by healthcare organization’s employees are analyzed and validated if legitimized. The scope of the accesses granted to HD4DP2 may differ, which is reflected in various user roles. Based on access rights, the following three user roles can be distinguished:

Local Study Lead (author):

The Local Study Lead can:  

  • edit and review all peer registrations (regardless of role) for the study or project;
  • make registrations in HD4DP v2.

This role might be, but should not be limited to, the individual responsible for the study or project within the participating healthcare institution.

Local Study Associate (author):

The Local Study Associate can: 

  • edit and review their own registrations, not those of other colleagues from the same healthcare organisation participating in the same study or project. The indicated registrations are limited to the patients treated by the Local Study Associate;
  • make registrations in HD4DP v2.

The Local Study Associate is a healthcare provider participating in the study or project. This is reflected in the registration form.

Local Study Support (co-author):

The Local Study Support can: 

  • edit and review registrations belonging to the author group they are linked to;
  • make registrations in HD4DP v2.

A Local Study Associate and Local Study Lead can delegate registration tasks to a Local Study Support. This might be, but should not be limited to, an administrative assistant or staff from a medical coding department. The Local Study Associate and Local Study Lead are still considered as the author of the registration; the Local Study Support is considered as the co-author. The Local Study Associate and Local Study Lead can view and modify Local Study Support entries.

The scope of the access rights is to prevent users of HD4DP v2 from seeing personal and sensitive information from individuals with whom they do not have a therapeutic relationship. The access rights therefore do not necessarily reflect the hierarchy within the healthcare organization. The healthcare organisation staff can consult their Data Protection Officer (DPO) for more in depth information concerning these access rights. It is up to the Access manager to approve or change roles from/to Local Study Lead, Local Study Associate and Local Study Support. These requests are carried out in the EAM system by the Access managers of each healthcare organization.

Remarks:

  • The scope of the access rights does not necessarily reflect the hierarchy within your healthcare organisation.
  • It is up to the Access manager to change roles from/to Local Study Lead, Local Study Associate and Local Study Support. These requests are carried out in the EAM system.