To ensure quality, reproducibility, planning, transparency, and prioritisation, all collaborations must be based on a well-founded project protocol—preferably in English—that outlines the project proposal in detail according to the following criteria:
- Background, including a systematic literature review if possible
- Participants, including the index population
- Subgroups and potential comparison groups in order of priority
- Objective and hypothesis
- Data
- Exposures (e.g., a specific treatment)
- Outcomes, prioritised
- Study period
- Statistical considerations
- Research team, including authorship considerations and order of authorship
- Project timeline
- Publication plan
We recommend publishing study protocols on the Real World Evidence Registry via the OSF platform before initiating data collection and analysis, especially for studies on medication and treatment effects.
If you wish to contact us, please reach out to the centre's director, Lone Graff Stensballe.
Relevant links, meetings, and events
For information on data approvals, visit: Danish Data Protection Agency and Data Approvals
For guidance on database development in REDCap, visit: REDCap