Webinar om kliniske databaser

The Guidance Function is hosting an online session about clinical databases

The Guidance Function is hosting an online session about clinical databases During spring of 2023, the Guidance Function is hosting a series of Danish online sessions regarding the different requirements and processes, researchers might encounter when applying for different types of data.The sessions consist of a brief introduction to the Guidance Function, a presentation of the session topic and a Q&A session. On March 31 at 13.00 – 13.30, we will conduct the webinar about clinical quality databases (RKKP). The session will focus on the rules and regulations when applying for access to RKKP. The session is set to last 30 minutes and are directed towards researchers and other interested parties, who work with health data and have interest in first-level guidance about the requirements and processes regarding access to health data. Register for the Danish webinar about clinical quality databases here: Tilmelding til webinar om Kliniske kvalitetsdatabaser You can also see all the Danish upcoming webinars on the Guidance function’s website: Webinars | Vejledningsfunktionen Contact the Guidance Function on info@vejledningsfunktionen.dk  or call us +45 2494 7969Monday to Thursday at 10-14Friday at 10-13 The Guidance Function offers first-level guidance on the requirements and permissions needed when applying for health data. Our services are free for both public and private clinicians and researchers, Danish as well as foreign.The Guidance Function is part of the public initiative The Research Health Data Gateway, and is a part of the new health data services initiated by the Ministry of the Interior and Health and Danish Regions. Looking forward to seeing you.  News from the Guidance FunctionWe welcome your suggestions for content for the Guidance Function newsletter. Please submit any suggestions to info@vejledningsfunktionen.dk. Opening hoursMonday – Thursday between 10:00 – 14:00Friday between 10:00 – 13:00Tel.: (+45) 2494 7969

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Case #17: Hvilken Videnskabsetisk Komité skal der anmeldes til?

Case #17: Which Scientific Ethics Committee must be reported to?

Case #17: Which Scientific Ethics Committee must be reported to?   Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration. A researcher contacted the Guidance Function with an inquiry regarding which scientific ethics committee the research project should be reported to. All health science and health data science research projects must be reported to a scientific ethics committee. (However, with the exception of some specified research projects, cf. the Danish Committee Act §14 subsections 2-5.)There are three different scientific ethics committees in Denmark to which research projects can be reported. The Regional Scientific Ethics Committees (RVK) The National Scientific Ethics Committee (NVK) The Scientific Ethics Medical Committees (VMK)  Depending on the type of research, reports must be made to one of the three committees mentioned. By default, health science research projects with humans, as well as experiments with tissues, cells, etc., must be notified to the regional committee for the regional area where the principal investigator works. (However, not drug trials or medical devices, as these have to be reported to VMK). If the trial is multicenter, you have to notify the regional committee for the area where the coordinating trial officer works Notification must be made to NVK if the research project involves extensive mapping of the individual’s genetic material, in which an exemption from the consent requirement pursuant to §10 of the Committees Act is applied for. For health informatics research projects with already existing genome data or already existing imaging data. In the case of psychosurgery or research on a deceased person as part of removal of their organ.  VMK must be notified if the research project includes clinical trials with medicinal products, clinical trials of medical equipment, or clinical trials of in-vitro diagnostic equipment.  For further information, visit the website for the National Center for ethics (in Danish): Hvortil skal jeg anmelde? | Nationalt Center for Etik In this case, we assisted the researcher to clarify which scientific ethics committee the research project should be reported to. We also included the information to the relevant scientific ethics committee in the region of the researcher.  Please feel free to contact us if you need guidance in your research project. Our services are free, and we aim to reply to any inquiries within 2-4 working days.The Guidance Function offers first-level support for Danish and international researchers in need of help to navigate the requirements and processes surrounding research projects. News from the Guidance FunctionWe welcome your suggestions for content for the Guidance Function newsletter. Please submit any suggestions to info@vejledningsfunktionen.dk. Opening hoursMonday – Thursday between 10:00 – 14:00Friday between 10:00 – 13:00Tel.: (+45) 2494 7969

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Adgang til data fra Rigsarkivet

Case #16: Access to data from the Danish National Archives (Rigsarkivet)

Case #16: Access to data from the Danish National Archives (Rigsarkivet)   Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration. A researcher contacted the Guidance Function with an inquiry about how to get access to data at the Danish National Archives. The Danish National Archives possesses two different types of datasets: Datasets that are freely available.These types of datasets do not require any approvals or applications before they can be accessed. These types of datasets typically contains data that is more than 20 years old and does not contain personal data. Datasets that are not freely available.These types of datasets requires permission from the National Archives before they can be accessed. Depending on how old and what type of data the dataset contains, the Danish National Archives is required to get special approvals, before they can hand over the dataset. a. If the dataset is less than 20 years old, the Danish National Archives must obtain an approval from the researcher or authority that created the dataset before they can pass it on b. If the dataset contains personal data that is less than 75 years old, the Danish National Archives must furthermore obtain an approval from the Danish Data Protection Agency, before the dataset can be passed on. For further information, visit the Danish National Archives website: Rigsarkivet – The Danish National Archives  In this case, we assisted the researcher to obtain an overview of how to apply for data at the National Archives depending on datatypes. We also passed on the contact information to the Danish National Archives so the researcher could contact them if specific questions arose about the individual datasets.  Please feel free to contact us if you need guidance in your research project. Our services are free, and we aim to reply to any inquiries within 2-4 working days.The Guidance Function offers first-level support for Danish and international researchers in need of help to navigate the requirements and processes surrounding research projects.  News from the Guidance FunctionWe welcome your suggestions for content for the Guidance Function newsletter. Please submit any suggestions to info@vejledningsfunktionen.dk. Opening hoursMonday – Thursday between 10:00 – 14:00Friday between 10:00 – 13:00Tel.: (+45) 2494 7969

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