Service description
We disclose registry data for clinical studies. You may only obtain data on study subjects who have given their consent to participate in the study. A prerequisite for data disclosure is that we can ensure an adequate level of data protection and information security in the processing of the data.
In the case of clinical drug trials, it is also required that the study has received a positive decision from Fimea. The need for registry data must be specified in the documentation submitted to Fimea when applying for authorisation for the clinical drug trial.
Act on the Finnish Institute for Health and Welfare, Section 5a (Finlex)
We may only disclose registry data that are necessary for the implementation of your study.
The right to access data applies only to the following registers:
- Data collected by THL pursuant to Section 5(1)(1) of the Act on the Finnish Institute for Health and Welfare.
- Act on the Finnish Institute for Health and Welfare, Section 5 (Finlex)
- Data on microbial findings in the Register of Infectious Diseases pursuant to Section 32 of the Communicable Diseases Act (1227/2016).
- Communicable Diseases Act, Section 32 (Finlex)
Submit the application to THL’s Registry Office using the application form and attach the required documents. In connection with a positive decision, you will receive instructions on how to submit a data request and the conditions for using the data.
Other legal grounds for data disclosure:
- Clinical Trials Act (983/2021), Sections 34 and 11 Regulates the disclosure of data and requires a positive decision from Fimea for the study.
- Clinical Trials Act
- Medical Research Act (488/1999), Section 21c
- Governs access to data for medical research.
- Medical Research Act
- Medical Devices Act (719/2021), Section 20a
- Defines the disclosure of data for medical device studies.
- Medical Devices Act
Who the service is intended for
The service is intended for sponsors, researchers, and research groups conducting clinical studies.
The service is not available to private individuals or consumers.
Fees
Decisions regarding the disclosure of registry data and data extraction are subject to a fee.
The fee for the decision is EUR 950 + VAT (25.5%), totalling EUR 1,193.
In addition, a fee is charged for data extraction. Further information on data extraction costs can be requested at
tietopyynnot(at)thl.fi.
The fees are based on Section 3, item 2 of the Ministry of Social Affairs and Health Decree on Chargeable Services of the Finnish Institute for Health and Welfare (106/2025), concerning decisions and services related to the use of the Institute’s sample and data materials and sample management services.
Ministry of Social Affairs and Health Decree on Chargeable Services of the Finnish Institute for Health and Welfare (Finlex)
How to contact us
Submit the application form and the attachments specified therein to THL’s Registry Office at
kirjaamo(at)thl.fi.
Instructions for sending encrypted email can be found on the Registry Office’s website.
Registry Office
Please note that identifying personal data of study subjects must not be included as attachments to the application. Instructions for submitting a data request will be provided as an annex to the positive decision.
Application for access to registry data for a clinical study (rtf, 178 KB) in finnish
Enquiries and further information:
tietoluvat(at)thl.fi