Setting up research projects: Administrative and legal demands

Resources for setting up research projects at SDCA, specifically with administrative and other legal demands.

Author
Affiliation

Sine Knorr Johnsen

Steno Diabetes Center Aarhus

Warning

🚧 This website and most of its contents are often updated or modified. Many documents are at various stages of completion. 🚧

Clinical studies

  • Preparing for a study
    • Research within the region (AUH) or University (AU)?
    • Report to VEK (obs research biobank vs biobank, research in children and whole genome issues)
    • Clinical Trials (report to clinicaltrials.gov and the Danish Medicines Agency (Lægemiddelstyrelsen))
  • Lab used?
    • M-lab
    • Patolab
    • Collaborating with dep. of biochemistry (klinisk biokemisk)
    • Biobank

Access to patient data (not with Statistics Denmark)

  • Research project or quality control study
    • Research project using Patient Data
      • Report to Styrelsen for patientsikkerhed - obs blev dette ændret
      • Attachment to the department where the patient data is being collected (get a unpaid job…)
    • Quality control study
      • Aquire permission from head of department

Report to Danish Data Authorities

Or in Danish, Datatilsynet - Paraply anmeldelse under RM eller via AU.

GDPR

  • Link to GDPR info: https://medarbejdere.au.dk/informationssikkerhed/databeskyttelse/

Storage of sensitive patient data

  • Storage at AU
    • Patient and trial data (patient sensitive): RedCap
    • Larger data files: O-drive, needs to be setup through AU-IT so that logging is possible. Only pseudonymized patient data.
    • Link to AU datastorage info: https://medarbejdere.au.dk/informationssikkerhed/klassifikation-af-data/#c2545048
  • Storage at RM
    • Patient and trial data (patient sensitive): RedCap through RM
    • Larger data files: MidtX, needs to be setup through RM-IT so that logging is possible.

Datahandling agreements