Parties and roles specific to R-RCT

Registry organisation

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

Central Personal Data Controller (CPUA)

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

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

Registry controller and registry steering committee

The registry controller 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 trial and the adaptation (technical) and management work required for the registry to be used in the trial. The trial 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/trial application into the registry. Contact with the supplier is through the registry controller 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 trial from the registry at the end of the trial
    
    
• User support functions
  • User administration
  • Publication of instructions and training courses
  • Support function
  • Case management
    
    
• Trial-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/trial application for building the R-RCT trial integrated into the registry. A specific technical solution/trial application needs to be developed for each individual trial.

Product owner

Successfully performing the necessary development requires a good understanding of the structure and criticality of the trial 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 trial's system requirements and for planning and implementing a good solution for the trial 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 trial also requires technical knowledge and expertise on frameworks and registries. Troubleshooting and corrections to the trial design occur even after a trial has started. This is usually handled by system developers but depending on the size of the trial, different levels of user support and/or project management may be needed.

Trial contact person (for the development and management of the trial)

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