The internal control system
The university must carry out internal control in a manner that is adapted to the size, nature, activities and risk factors of the research. The person/entity responsible for research must see to the preparation and documentation of procedures that enable the project manager and project team members to comply with the requirements in effect for medical and health research.
Responsibility and authority relationships are shown in the list of authorizations. The role descriptions specify the duties of the person/entity responsible for research ("forskningsansvarlig"), the project manager and the project team members.
The internal control system describes the process from planning of the research project until its completion. The system emphasizes the requirements that must be satisfied so that the research complies with the regulations for medical and health research.
The project manager must involve the person/entity responsible for research (RR) before the project starts, and the RR must assess whether the project is consistent with the unit's strategy and whether the necessary resources are available. The Faculty of Medicine is in the process of developing a system for secure storage of personal data, both for active research data and long-term storage of research data.
The internal control system describes the requirements for risk assessments and procedures dealing with non-conformances, who must be notified of non-conformances and who is responsible for ensuring that non-conformances are rectified.
The person/entity responsible for research must monitor the project portfolio. To ensure that research projects are carried out in accordance with the protocol, procedures and legislation, the person or entity responsible for research must conduct an annual check of a sample of projects in different phases (start-up, implementation and completion). Non-conformances must be rectified. If research violates the permissions that have been granted and it is not possible to rectify the situation, the research must be stopped.
In the management communications with his or her superior, the person/entity responsible for research must report on the research activities at the unit, compliance with legislation and procedures, and the quality system used.
More detailed information is available under planning, implementation and completion of research projects.
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Version 1.0. Date: 1 January 2012