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Useful links regarding law, approvals and more

Law - notifications and approvals

Danish Data Protection Agency, OUH
Procedures and terms for notification of projects to the Danish Data Protection Agency under the collective permission held by the Region of Southern Denmark.

Danish Data Protection Agency, SDU 
Procedures and terms for notification of projects to the Danish Data Protection Agency under the collective permission held by the University of Southern Denmark.

The Health Research Ethics Committee
Information regarding notification to the Ethics Committee as well as requirements and guidance.

The National Health Research Ethics Commitee
Find information on the requirements for your research project, procedure for application, information on rights as a test subject as well as practical information about the National Research Ethics Committee.

Danish Medicines Authority - Applications
Guideline for applications for authorisation of clinical trials of medicinal products in humans.

Danish Patient Safety Authority
Read about disclosure of patient-journal information.

Safety measures for the protection of personal data
Guidelines to ministerial order no. 528 of June 15th 2000 on the security measures for protection of personal data processed for the public administration.

Danish Data Archive - DDA
DDA collect, preserve and deliver research data. DDAs main activities are focused on assisting researchers and students who needs data delivered or need to deliver data to DDA.

The Law Portal, OUH
Via OUH's Intranet you are able to find examples of the consent forms, information on legislation for disclosure of information from databases, research projects and more.

Guideline for Good Clinical Practice (ICH-GCP)
European Medicines Agency’s Guidelines: ICH Harmonised Tripartite Guideline for Good Clinical Practice, can be found via the GCP-Unit's website

GCP-Executive order
Legal Information: Executive order of good clinical practice in the clinical trials on humans

Counselling, guidance and monitoring

GCP - Good Clinical Practice
Joint website for all regional GCP-units.

Regional Coordinator – One entrance – South
The Region of Southern Denmark has employed a Regional Coordinator for the One entrance for the industry to clinical research in Denmark policy. Regional Coordinator Charlotte Calov is affiliated to the GCP-unit and may be contacted at: ccalov@health.sdu.dk.

Research Infrastructure in the Region of Southern Denmark
Website containing links and procedures useful in the research process.

OUH's Research Portal
Guidelines for research e.g. concerning notification of OUH research projects to the Danish Data Protection Agency, useful links (GCP-unit, research reports etc.), call for research grants and much more.

Research at OUH
Read more about research at OUH, the research strategy, infrastructure and more.

Free statistic advice
10 hours of free statistic advice at Research Unit for Epidemiology, Biostatistics and Biodemographics, targeted PhD-students and other researchers at The Faculty of Health Science.

Get started on clinical research
Danish guide on preparation and approval of clinical studies, compiled by Ministry of Interior and Health, the Danish Medicines Agency and the National Committee on Health Research Ethics.  

Consort
Tool for project planning as well as completion of the article.

Registers and databases

The database unit in the Region of Southern Denmark
Offers easier access to the use of databases for employees in the Region of Southern Denmark

Competence Centre South for Nationwide Clinical Databases
Competence Centre South has the regions quality databases and does research within this area.

Tissue use register
Information on the act of September 1st 2004 on the change in patients' legal position.

Clinical Trials
Registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. .

Clinical Trials Register
The EU Clinical Trials Register website allows you to search for protocol and results information on interventional clinical trials which are conducted in the European Union (EU).

Denmark's National Biobank
Search for biological material in the Danish Biobank Register

Conference planning

OUH's conference site
At OUH conference site, you are able to find references to who is able to help you get started. Inspiring Denmark can help promote your candidacy for hosting. OUH can assist in publishing.

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