Register-based research

Steno Diabetes Center Aarhus (SDCA) is registered at Scientific Services at Statistics Denmark (DST), (authorisation no. 574). Head of Unit, Annelli Sandbæk is responsible for the authorisation and must approve and sign all recommendations for research projects at DST. Adam Hulman is the substitute and Kasper Norman and Else-Marie Dalsgaard are administrators.

Who can get access?

• Researchers employed at SDCA.
• External researchers participating in projects if they collaborate with researchers employed at SDCA. It is thus required to make a data processing agreement.

It is the responsibility of the project manager to make data processing agreements with relevant external researchers.

At the end of employment (handing in of PhD dissertation or termination of employment), a data processing agreement must be made if the researcher should continue to have access to DST through SDCA.

All handling of data must comply with current legislation and DST rules on data security. If security regulations are violated, sanctions are significant. DST will usually terminate all access for a specifically defined period of time. During this period, all researchers at SDCA will be excluded from accessing their project. Repeated violation of data security regulations will lead to tightening of sanctions. Detailed guidelines are available for SDCA employees on our shared drive (N:\Afdeling\AUHSTDIC\Forskning\DST_materials\).

Adam Hulman must approve results for all researchers working in accordance with the SDCA authorisation. Aut  horised researchers with several years of experience in working at DST can apply for permission to transfer data themselves. The person responsible for authorisation can decide if this permission should be given.

Detailed guidelines are available for SDCA employees on our shared drive (N:\Afdeling\AUHSTDIC\Forskning\DST_materials\).

1. The research project has to be sent to the Central Denmark Region internal registry of research projects before sending an application to DST.
   
   
2. The researcher prepares project proposal and list of variables (use latest template from DST).
   
   
3. Project proposal and appendices are sent to DST and DST issues a filing number.
   
   
4. An application has to be sent to the Danish Health Data Authority (Sundhedsdatastyrelsen), if the project uses data from this service. Please note that applications to the Danish Patient Registry and the Medicines Registry (Lægemiddelstatistikregistret) must always be sent directly to the Danish Health Data Authority.
   
   
5. The project proposal must be signed by Annelli Sandbæk, Head of Unit, and returned to DST approval.
   
   
6. All new researchers must participate in the SDCA course on data security before getting access to DST.
   
   
7. Administrators make affiliation agreements in FSE-BOA. If new researchers are not already registered in FSE-BOA, administrators contact Scientific Services at DST.
   
   
8. Annelli Sandbæk (authorisation responsible) or Adam Hulman substitute must approve the affiliation agreement.
   
   
9. Researchers receive an email from FSE-BOA about approval of the affiliation agreement and instructions on how they approve the agreement in FSE-BOA. In a separate email, the researcher receives information on how to access and log-on to DST.

When registering a new research project, the Central Denmark Region internal register of research projects (Region Midtjyllands interne registrering af forskningsprojekter) must be notified here.

NB: Researchers employed at Aarhus University register research projects in the internal register of research projects at the university.

Research projects involving patient contact must be approved by The Central Denmark Region Committee on Health Research Ethics here.

There is a checklist at the committee’s website of all items to be included as appendices for the application (i.e. protocol, invitation letter, consent form, participant information, protocol summary). The application form is to be filled out online, printed and then signed by the data responsible and returned with signature to the committee including appendices.

Contact the committee by phone to request if your project needs to be approved. If this is not necessary, it may be a good idea for publication purposes to get a written legal assessment (e.g. by email).

If the project wishes to use data from medical records without patient consent, approval must be obtained from Central Denmark Region here.

Please read 'Terms and conditions' for working at Statistics Denmark authorised by Steno Diabetes Center Aarhus:
Access only for SDCA employees - (N:\Afdeling\AUHSTDIC\Forskning\DST_materials\)

The DST application form is found here.

The application is followed by a complete list of:

• Registers, tables and variables at DST you wish to access
• External data
  • a) own project data and
  • b) data from other registers such as Danish Health Data Authority (Sundhedsdatastyrelsen) (most health registers are already at DST, but for some registers, an application must be sent directly to the Danish Health Data Authority).

Overview of DST registers and variables.

Find examples in other applications and ask for the support from experienced users
Access only for SDCA employees

• N:\Afdeling\AUHSTDIC\Forskning\DST_materials\

Access to data from the Danish Health Data Authority can be applied for electronically here.

The application must contain

• Project description
• Description of data extract
• Approval by the Central Denmark Region internal register of research projects
• Project number and contact person at Statistics Denmark if relevant
• Approval by the Central Denmark Region Committee on Health Research Ethics, if required

It is important to read the guidelines for project and extract of data descriptions at the website. Find the guidelines here.

The description of data extract must include tables and variables applied for as well as the time period and argument for access to specific data.

Find an overview of registers and variables as well as requirements for data extract here.

If you wish to collaborate with researchers from another legal authority (such municipality, university), this collaboration must be defined. It could involve

1. a data processing agreement
   The data owner defines the research question, and the data processor acts (on instruction). Before access to data, the data owner drafts a data processing agreement signed by the data processor
   
   or
   
   
2. a data transfer agreement
   The receiver of data defines the research question, registers the project at the Danish Data Protection Agency and receives data from the data owner.

When drafting data processing agreements or data transfer agreements, it is recommended to contact Legal Services, Central Denmark Region