12. Monitor and review implementation of the projects
The person responsible for research (Head of Department / Dean / Head of the Unit) must monitor the project portfolio. The database of the regional committee for medical and health research ethics (REK) is searchable and provides an overview of the portfolio.
The person responsible for research (RR) must also take systematic measures to ensure that the project is conducted in accordance with the guidelines for medical and health research, that the necessary approvals have been received and processing of personal data complies with laws, regulations and the institution's own guidelines.
If the RR discovers non-conformances, the routine for handling non-conformances must be followed.
A sample of 10% of all the research projects must be checked each year, and the sample must be selected from different phases of implementation: start-up, implementation and completion.
Review of implementation
Every year, the RR checks that medical and health research projects have obtained the necessary approvals, and are being conducted in accordance with law and with the information specified in the approved application or notification of a change.
Review at project completion
The RR checks whether the procedures related to completion have been followed and that research data that has been stored electronically or in other archival systems have been deleted or anonymized.
In the communications with his or her manager, the RR must report on the level of compliance with laws and procedures, the measures that have been taken and whether the quality tool has been used.
External audits (oversight)
External audits may be conducted by the Norwegian Board of Health (Statens helsetilsyn) and the Norwegian Data Inspectorate (Datatilsynet). For projects involving administration of medicines to human subjects, the Norwegian Medicines Agency (Statens legemiddelverk) may also provide oversight. For projects that include the use of medical equipment the Directorate of Health (Helsedirektoratet) or the Directorate for Civil Protection and Emergency Planning (Direktoratet for samfunnssikkerhet og beredskap) may provide oversight.
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Version 1.0. Date: 1 January 2012