Roles specific to R-RCT

Registry organisation

Responsibility and management in an R-RCT can be shared between several roles: the central personal data controller, the registry holder and the registry steering committee. Other stakeholders in an R-RCT are the registry centre, any technical supplier and the contact person for the study.

Central Personal Data Controller (CPUA)

The central personal data controller (CUPA) is the authority that has the central responsibility for personal data in a quality registry. The planning of the study is between the researcher and the registry holder/registry steering committee, but it is desirable that the CPUA authority is informed about the study. Contact with the CPUA authority is through the registry holder.

It is also the CPUA authority that decides on the release of data from quality registries. The release of data for the study is done by applying for data extraction via the CPUA authority and registry data extraction process.

Registry controller and registry steering committee

The registry holder and the registry steering committee are groups that work on the content of the registry and are responsible for the main direction and operation of the registry. The registry steering committee of the registry to be used for an R-RCT must approve the study and the adaptation (technical) and management work required for the registry to be used in the study. The study must be able to cover the costs involved.

Registry centre

Registry centres are regional organisations that support quality registries with start-up, operation, improvement work and performance analysis. A registry centre may also be the provider of the technical platform used by the registry. The provider responsible for managing the registry platform must be engaged to integrate a technical solution/study application into the registry. Contact with the supplier is through the registry holder and/or registry centre. An R-RCT generally involves several organisations, so management tasks must be appropriately distributed among the organisations involved. This varies from case to case.

Examples of key management functions include:

• Technical management
  • System monitoring
  • Maintenance and updates
  • Error management
  • Removal of the study from the registry at the end of the study
    
    
• User support functions
  • User administration
  • Publication of instructions and training courses
  • Support function
  • Case management
    
    
• Study-related tasks
  • Production and processing of statistics for sub-analyses
  • External communication
  • Risk management
  • Submission to the safety committee

Product owner and system developer

In cases where an R-RCT is implemented by integrating one or more data collection steps with an existing registry, development in the relevant registry is needed. If registry platforms use an R-RCT framework, this means system development of a technical solution/study application for building the R-RCT study integrated into the registry. A specific technical solution/study application needs to be developed for each individual study.

Product owner

Successfully performing the necessary development requires a good understanding of the structure and criticality of the study and a good communication between the managers and developers of the relevant systems. The person responsible for setting the requirements for the IT solution for each registry is a product owner/development manager etc. In this text, this role is referred to as product owner. The product owner is responsible for understanding the study's system requirements and for planning and implementing a good solution for the study and the registry. It is the product owner who usually communicates with system developers. It is particularly important to pay attention to the interfaces and integration between interacting systems.

System developers

The management of the systems during the study also requires technical knowledge and expertise on frameworks and registries. Troubleshooting and corrections to the study design occur even after a study has started. This is usually handled by system developers but depending on the size of the study, different levels of user support and/or project management may be needed.

Study contact person (for the development and management of the study)

The study should appoint a study contact person who should be involved in the study and familiar with the registry. They may also be called project managers or study coordinators. This role is the contact person for the study/registry with the product owner, who will develop the technical solution/study application in the registry.