Good Clinical Practice and GCP units

November 28, 2023

Good Clinical Practice and GCP units The Guidance Function frequently receives inquiries regarding assistance with the regulations governing trials with medicine and medical equipment. Therefore, we would like to share this information and, in this newsletter, elaborate on what Good Clinical Practice entails and how GCP units can provide assistance. Good Clinical Practice (GCP)GCP is an international ethical and scientific quality standard for the conduct of a clinical trial involving human subjects. GCP describes the ethical and scientific aspects of a clinical trial and could be descripted as the clinical trial’s “ISO standard”. GCP includes all aspects of a clinical trial, from the planning phase, the implementation of the project, and the reporting of the results. The purpose of GCP is to ensure that the subjects’ rights, safety and well-being are safeguarded. Furthermore, ensuring that the collected data is valid, complete, and well documented. Futher information about Good Clinical Practice can be found at the GCP units’ collective website (in Danish): GCP og Lægemiddelforsøg – GCP-Enhederne GCP unitsIn Denmark, we currently have three GCP units: Aalborg/Aarhus covering the North Denmark Region and Central Denmark Region, Odense covering the Region of Southern Denmark, and Copenhagen covering Region Zealand and the Capital Region of Denmark. In 2024, an independent GCP unit will be established in Aalborg for the North Denmark Region. These GCP units offer guidance and monitoring for trials with medicine and trials with medical equipment to ensure compliance with GCP guidelines. They provide monitoring services for clinical trials with medicine led and initiated by non-commercial or public researchers affiliated with university hospitals, regional hospitals, and universities in Denmark. This service extends to all public trials that require notification to the Danish Medicines Agency. Each GCP unit has its own regional website and contacts, which can be found on the respective regions’ websites or on the GCP units’ collective website: GCP-unit.dk. Here, more in-depth information about GCP is available, along with access to a Danish e-learning module providing a comprehensive introduction to Good Clinical Practice and its components. Remember that the Guidance Function is a free advisory service for both public and private researchers, both Danish and international. You can always reach out to us at info@vejledningsfunktionen.dk or call us at +45 2494 7969. 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

Hvilken videnskabsetisk komité skal der anmeldes til

Which Scientific Ethics Committee must be reported to?

November 21, 2023

Which Scientific Ethics Committee must be reported to? The Guidance Function often receives inquiries regarding which Scientific Ethics Committee a research project should be submitted to. Therefore, we have created an overview of what needs to be submitted to each committee. 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 to be conducted, reporting needs to be made to one of the three mentioned committees: Regional Scientific Ethics Committees (RVK) In principle, health science research projects involving humans and experiments involving tissues, cells, etc., should be reported to the regional committee covering the area where the principal investigator works (excluding drug trials or medical devices, as these fall under VMK). In multicenter trials, reporting should be made to the regional committee where the coordinating principal investigator works. National Scientific Ethics Committee (NVK) Reporting should be made to NVK for research projects involving particularly complex areas: Extensive mapping of an individual’s genetic makeup with a request for dispensation according to § 10 of the Committee Act Psychosurgery Research on a deceased person as part of organ removal Health data science research projects without biological material but with already existing genomic data or existing image diagnostic data Scientific Ethics Medical Committees (VMK) Reporting should be made to VMK for research projects involving: Clinical trials with medicine (Reported through the Clinical Trials Information System (CTIS)) Clinical testing of medical equipment Clinical testing of in vitro diagnostic equipment You can find more information about what needs to be reported and where to report on the National Centre for Ethics’ website (in Danish). Hvad skal jeg anmelde? | Nationalt Center for Etik Hvortil skal jeg anmelde? | Nationalt Center for Etik On the Guidance Function’s website, you can find guides to data access and approvals, where you can read more about how to apply to the Scientific Ethics Committees and find links to the individual Regional Scientific Ethics Committees. Remember that the Guidance Function is a free advisory service for both public and private researchers, both Danish and international. You can always reach out to us at info@vejledningsfunktionen.dk or call us at +45 2494 7969. News from the Guidance Function We welcome your suggestions for content for the Guidance Function newsletter. Please submit any suggestions to info@vejledningsfunktionen.dk. Opening hours Monday – Thursday between 10:00 – 14:00 Friday between 10:00 – 13:00 Tel.: (+45) 2494 7969

Access to patient record data

November 14, 2023

Access to patient record data The Guidance Function often receives inquiries regarding access to patient record data. We have therefore created an overview of how patient record data can be accessed.There are generally four ways of obtaining permission to gain access to patient record data: 1. Patient consentYou can acquire permission to access patient records by obtaining written consent from the patient. However, you should be aware that consent lapses no later than 1 year after it has been given, and must be obtained once again. 2. Approval from a scientific ethics committeeIf the research project requires the approval of a scientific ethics committee, e.g. if the project contains human biological material or sensitive bioinformatic data, etc., then you can also be approved to obtain patient record information through this. Read more about what must be reported to the Scientific Ethics Committee on the following website (in Danish): Hvad skal jeg anmelde? | Nationalt Center for EtikIt must be emphasized that permission is only given for the disclosure of patient record information, i.e. the researcher must personally contact the department in question, which must hand over the patient record information and make a further agreement about the record extract. 3. Approval from the Regional CouncilIf the research project does not require scientific ethics approval, the regional council in the region where the researcher works can grant approval for disclousre of patient record information.Again, it must be emphasized that permission is only given for the disclosure of patient record information, i.e. the researcher must personally contact the relevant department that must hand over the patient record information and make a detailed agreement on how the data is handed over. 4. Quality assurance or quality development projectsThe management at the treatment facility, cf. section 42 d, subsection of the Health Act 2, can only approve the acquisition of patient record information for use in quality assurance or quality development projects.In some cases, it can be difficult to define whether one’s project is a research or quality project. In case of doubt, it is recommended to contact the local hospital management for clarification. On the Guidance Function’s website, you can find guides to data access and approvals, where you can read more about how to access patient record data, as well as links to the Regional Councils. Remember that the Guidance Function is a free advisory service for both public and private researchers, both Danish and international. You can always reach out to us at info@vejledningsfunktionen.dk or call us at +45 2494 7969. 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

Nyhedsbrev uge 45 danske og engelske webinar videoer

Danish and English webinar videos

November 7, 2023

Danish and English webinar videos The Guidance Function has hosted webinars in 2023 about various data sources and the requirements and processes that researchers may encounter when applying for different types of data. Due to high demand, we have created videos of our webinars in Danish before the summer holidays, and all of them are now available on the Guidance Function’s website. As the Guidance Function also has many international users and inquiries, we have during the autumn, launched English videos of the webinars.We are now pleased to present the final English webinar video on biobanks, which has just been released on the Guidance Function’s website. In the video, we present what biobanks are and how they can be used in health data research. The video also provides an overview of the most essential aspects of biobanks and talk about Bio- and Genome Bank Denmark and The Danish National Biobank. You can find both Danish and English webinar videos on the website covering the following topics: Biobanks Clinical trials Clinical quality databases Registry data Patient record data All the Danish webinar videos can be accessed through our website here: Videoer af webinarer | Vejledningsfunktionen and all the English webinar videos can be accessed through our website here: Videos of webinars | Vejledningsfunktionen The Guidance Function would like to thank all stakeholders who have contributed to ensuring the quality of the videos and hopes that this initiative can contribute knowledge to simplify access to health data. Remember that the Guidance Function is a free advisory service for both public and private researchers, both Danish and international. You can always reach out to us at info@vejledningsfunktionen.dk or call us at +45 2494 7969. 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

Good Clinical Practice and GCP units

Which Scientific Ethics Committee must be reported to?

Access to patient record data

Danish and English webinar videos

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