Research involving humans
The Swedish Act Concerning the Ethical Review of Research Involving Humans and the EU General Data Protection Regulation (GDPR) apply for all research that involves humans.
You can find more information about this on the University’s web pages about research ethics:
UCR offers support for clinical research
As a researcher at the Disciplinary Domain of Medicine and Pharmacy, you can contact UCR to receive support for clinical research, e.g. a clinical study or trial. Areas where they provide support include GCP studies, randomized clinical studies, observation studies and medical technology studies. The earlier in the research process you contact UCR, the better are the chances that they can help you in the best possible way.
UCR grants access to the CTIS platform
Applications for clinical trials of human pharmaceutical products are submitted to the EU portal CTIS. For Uppsala University, UCR grants access to the CTIS platform and registers the study.
UCR offers two levels of support:
- Level 1 (compulsory): UCR registers the study in CTIS and the researchers handle the whole application process by themselves.
- Level 2: UCR registers the study and assists the researcher with the application.
More informationabout CTIS on the UCR web (in Swedish)
Pharmaceutical products insurance in clinical trials
Uppsala University has a pharmaceutical insurance that covers individuals who receive drugs when they participate in a clinical trial. Before the trial is initiated, a notification of a clinical trial should be submitted to Uppsala University’s Security and Safety division.
More information about the Pharmaceutical products insurance