User roles in HD4DP v2

Last updated: 2023-03-08 17:49

Each healthcare organisation has an Access Manager who watches over the access rights to the applications of the own organisation and manages them in the HD Entity Access Management (EAM) system. In this process access requests by healthcare organisation employees are analysed and validated if legitimised. The scope of the accesses granted may differ, which is reflected in various user roles. Based on access rights, 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 responsible for the study or project within the participating healthcare institution.

Local Study Associate (author):

The Local Study Associate can: 

  • edit and review the 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 the author of the registration; the Local Study Support is considered the co-author. The Local Study Associate and Local Study Lead can view and modify Local Study Support entries.

By default, only 1 Local Study Lead is intended by healthdata.be (Sciensano) for each project within each organisation. The idea is that only one person is meant to see all submissions for that project within that organisation. This policy prevents users of HD4DP v2 from seeing personal and sensitive information from individuals with whom they do not have a therapeutic relationship. For policy deviations on this, healthcare organisation staff should contact their Data Protection Officer (DPO). 

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.