Using Registry Data

Data collected in a quality registry may be used without further approvals to create reports and statistics if the purpose is to either improve patient treatment, or to give the hospital information regarding the quality of the treatment within a clinic or department.

However, if data is to be included in research studies, an approval must be made for this purpose. The same requirements apply when using data from the long-term research registries. Such an "approval" is ensured by reporting the research activity via an electronic notification form at Oslo University Hospital (OUS). Studies that fall under the Health Research Act will need an approval from the Regional Committees for Medical and Health Research Ethics (REK).

Use

The use of registry data for a research study entails storing data in pseudonymised form in a secure and approved storage area. Pseudonymised data means that directly identifiable characteristics, such as an 11-digit birth number and name, have been removed and replaced with a study-specific ID number for each participant/patient. A so-called "code list" is created containing the birth number, name, address, telephone number and similar information, as well as the associated study-specific ID numbers. At OUS, the list must be stored in Medinsight. At other hospitals you will save the code list according to the internal guidelines that are available.

 

Access to Data

If you wish to have access to data from a national medical quality registry, or from a central health registry (e.g. the Cancer Registry, the Prescription Register, the Norwegian Patient Register etc.), from other national "non-medical" registries (e.g. educational data from Statistics Norway), or from a broad-based research registry (e.g. MoBa study), access to data must be sought. You can apply for access to data from central health registries, national medical quality registries, and data from large national health surveys using http://www.helsedata.no/.

For health research, application is done by seeking REK for an ethical assessment and prior approval, as well as applying to every single register where data will be provided. If you are planning to link/merge data from multiple registries within a research study, you may also want to create a linkage/merging plan. Such a plan details which registries and data should be used, as well as the order in which data should be merged together. Some registries have clear rules for how the order in such a linkage should proceed, and this is a good idea to have clarified in advance by contacting the relevant registries. Applying for and linking/merging data from multiple registers may be time consuming - so it is advisable to contact all the registers involved and prepare the case process and the merging plan as early as possible.

Data Administration

When submitting data from a quality or long-term research registry, it is important that registry owners create an overview of all data files that are handed out from the registry. Such an overview will indicate the basis for processing the data, the name of the project owner, the name of the project, and where the data is stored. It is also wise to describe where the code list is stored, as well as the end date of the project where the data release is included.

Data Storage

All data storage within a quality- or research registries must be done in an approved storage area or in an approved database solution/application.