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How to report a clinically significant finding to Findata

  1. Fill in the following forms:
    • Annex 1: Enter the subject’s pseudonym / personal identity code and project details on the form. Personal data will be kept separate during the process to avoid unnecessary identification of the subject and to enhance data protection.
    • Annex 2: Fill in the relevant information on the form regarding the finding and any characteristics of the subject.
    • THL experts do not have access to the patient’s health data for the purpose of making the decision, so the decision will be based on the information provided.
  2. Send an email to data@findata.fi, stating that you wish to report a significant clinical finding.
    • Do not send personal data by email!
    • Use the following subject line: Clinically significant finding.
  3. You will receive a reply message with instructions on how to deliver the information to Findata.
    • Personal data must be delivered securely via the Tunneli transfer service.
    • If you do not have Tunneli credentials, order them according to the instructions: Data transfers to Findata.
      • See the section Open the Tunneli connection.
      • In the credentials order form, enter the case number of the data permit based on which the clinically significant finding was identified (e.g.). Enter “pykälä55” in the Identifier field.
    • If you already have Tunneli credentials, we will share a Tunneli folder for you to deliver the information. Transfer the files according to the instructions: Data transfers to Findata.
      • See the section “Encrypt your data resource and transfer it to Tunneli”.
      • Once you have delivered the files, notify us by email at data@findata.fi
  4. Deliver the following documents to Findata via Tunneli:
    • Annex 1
    • Annex 2
    • Research plan and summary of the research plan (including the research group’s contact details)

The Finnish Institute for Health and Welfare (THL) will process the findings within approximately four weeks. During holiday periods, processing may take longer. The permit holder will not be automatically notified of the decision. If desired, the permit holder may request confirmation that the finding has been processed, but not information on the outcome of the decision.