Case 14. Good clinical practice og GCP-enheder

Case #14: Good Clinical Practice and GCP units

Case #14: Good Clinical Practice and GCP units  Cases are examples of questions and inquiries we recieve in the Guidance Function, which we would like to share for inspiration. A researcher contacted the Guidance Function with an inquiry regarding a clinical trial and asked for information about what Good Clinical Practice means. Good Clinical Practice (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 taken care of. Furthermore, ensuring that the collected data is valid, complete, and well documented. In Denmark there are three GCP units located in Copenhagen, Aarhus/Aalborg and Odense. The GCP units offer guidance and monitoring of medicine and medical device trials to ensure the GCP guidelines are fulfilled. The GCP units offers to be responsible for the monitoring of clinical medical trials, which are led and initiated by non-commercial or public researchers affiliated with university hospitals, regional hospitals and universities in Denmark. This offer applies to all public trials that are obligated to notify the Danish Medicines Agency.Further information can be found at the GCP units’ website: English – GCP-Enhederne, GCP og Lægemiddelforsøg – GCP-Enhederne In this case, we assisted the researcher to achieve an overview of what Good Clinical Practice is and introduced the researcher to the GCP units. We also included links to the GCP unit’s general website and a link and contact information to the GCP unit 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. Contact information:Mail: info@vejledningsfunktionen.dkTel. +45 2494 7969

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Case 13. Hvad er en fortegnelse?

Case #13: What is a record of processing activities?

Case #13: What is a record of processing activities?   Cases are examples of questions and inquiries the Guidance Function receives, which we would like to share for inspiration. A researcher contacted the Guidance Function with a query regarding what a record of processing activities is and where it should be registered. A record of processing activities is an administrative record of who processes personal data and for what purposes. Formerly the Danish Data Protection Agency was responsible for the statement, but since the Data Protection Regulation came into force, the responsibility passed to the institution responsible for the data (e.g. the region).The Data Protection Regulation requires that all data controllers and data processors keep internal records of their processing of personal data. The purpose with keeping a record is to obtain an overview of the projects that are dealing with sensitive personal data. This overview is a prerequisite for complying with a number of obligations in the data protection regulation. The records must be available both in writing and digitally. The notification of the record of processing activities is usually conducted to the institution where the project manager is employed. If the research originates from a hospital, it will most often be the region, but it could just as well be a university or a company. An approved notice gives permission to process and store sensitive personal data in relation to the research project, and you can proceed to apply for permission for data transmission and data access. It is essential to emphasize that the requirement to keep a record of processing activities is solely intended as an “internal” obligation. Meaning that registration of the record at the Danish Data Protection Agency is only conducted on request. For further information (in Danish), click here.   In this case, we assisted the researcher to acquire information about a record of processing activities and whom it should be registered to. We also passed on a link to the Danish Data Protection Authority’s guide, where the researcher could find more information. 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. Contact information:Mail: info@vejledningsfunktionen.dkTel. +45 2494 7969

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Billede af Danmark med teksten Få besøg af Vejledningsfunktionen

Get a visit from the Guidance Function or participate in an online meeting with us

Get a visit from the Guidance Function or participate in an online meeting with us   The Guidance Function is part of ‘The Research Health Data Gateway’, which is the Danish Ministry of Health’s and the Danish Regions’ new health data service. We are very interested in presenting our services at The Guidance Function, and inform how we can assist you with your research project. We offer onsite visits at your department regardless of your location in Denmark or we can set up an online meeting. The Guidance Function offers first-level guidance on the requirements and permissions needed when applying for health data. We provide information on which authorities to contact and in which order in relation to your project, and thereby aiding to create an overview of the application process of requiring health data. The inquiries we receive are very different, such as questions regarding applications for specific databases, the requirements for different types of research projects, or permission for using Danish health data in foreign research projects. The Guidance Function services are free for both public and private clinicians and researchers, Danish as well as foreign.

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