The regional nodes that collaborate within Clinical Studies Sweden identify joint national challenges. The nodes collaborate in ‘development initiatives’ to find solutions to these.
The development initiatives, funded by the Swedish Research Council, can be implemented in various ways, such as pilot studies, inquiries or projects, depending on what the achievement aims are. The results of the development initiatives are implemented, disseminated and used in various ways. They may consist of procedure developments, templates, networks, etc., which simplify the work of clinical studies. The administration of the support developed is usually handled by the nodes.
Information about: Clinical Studies Sweden
GDPR - what applies to healtchcare, sponsor (academy / company) and patient?
The purpose of the initiative is to create a national consensus regarding the interpretation of the GDPR regarding the processing of personal data in the implementation of clinical studies. The aim is to produce advisory support for the nodes' staff, proposals for contract templates and research person information, as well as guidelines for personal data responsibility for data exchange between regions and the university.
Promote dental research; an investigation of possibilities for support from Clinical Studies Sweden
The initiative aims to investigate researchers' need for support for conducting clinical research in dentistry and in what way Clinical Studies Sweden can support this. The goal is to provide proposals for future development initiatives to promote dental clinical research in Sweden.
Revision of the simplified agreement process
The initiative aims to inventory, quality assure and update templates and documents from previous development initiative "Standardized process for agreements between sponsors and principals".
- Satellite sites,enabling shared study work between several healthcare principals, clinics and units
- National collaboration regarding monitoring services
- National network for research nurses - prestudy
- Standardised process for contracts between sponsors and principals
- Cooperation on quality systems and work processes
- Support measures for clinical studies in medical devices
- Information on clinical studies on medical devices
- Mapping and needs' analysis of clinical studies training
- National data collection system
- National standard R-RCT
- Research subject survey
- Statistics and follow-up on clinical studies
- National website for clinical studies
- Implementation of cooperation on quality systems and work processes
- Establishment of a national working group for clinical studies on medical devices