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Monitoring in Norway

Monitoring in Norway. Birgitte Lid Adamsen. 25 monitors. Ålesund. Fredrikstad. Figure 1: Number of monitors in Norway. Collaborations. Standard Operating Procedures Collaborates to monitor multi-center studies Comparable price policy (a dvicing are free of charge )

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Monitoring in Norway

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  1. Monitoring in Norway Birgitte Lid Adamsen

  2. 25 monitors Ålesund Fredrikstad Figure 1: Number of monitors in Norway

  3. Collaborations • Standard Operating Procedures • Collaborates to monitor multi-center studies • Comparableprice policy (advicing are free of charge ) • Website: https://www.norcrin.no/

  4. Collaborations – cont. • Co-monitoring: Exchange experience and possibleclarify the need for training • Each monitor should ideallyparticipate in a co-monitoringvisiteveryotheryear • National monitoringgroup: Twomeetings a year: • At one of thesemeetings, The Norwegian Medical Agency (NOMA) attends

  5. Collaborations – cont. • In multi-center studies, monitors monitor in each of their health regions. At the meeting (always): Discuss challengers and possible solutions, share useful information and share good tips • Next meeting: Discuss template monitoring reports • The purpose is to create a guideline describing how to fill out monitoring reports

  6. The Norwegian Medical Agency Figure 2: The number of applications that commercial and non-commersial sponsors has sent to NOMA from 2006 – 2017 Trials withmedicinalproducts Total Commercial sponsors (pharmaceutical industry) Non-commersial (investigator-initiated) sponsors

  7. Clinical studies Status September 2018 • 96 % medicinalproducts • 4 % medicaldevices  Otherintervention Figure 3: Total numbers of clinical drug and medicaldevice studies in Norway, except from Bergen and Ålesund

  8. News

  9. News • St. Olavs hospital (Trondheim): It is going to be established a CTU (Clinical Trial Unit): uncertain when it happens • University Hospital of North Norway (Tromsø): REDCap is approved as a data capture system

  10. News – cont. • Østfold Hospital (Fredrikstad): It is going to be established a CTU (decided by the director of the hospital) • Interview of possible candidates for the position as research coordinator has started

  11. Oslo University Hospital • CTU was established 1st of Sept. 2017, currently 31 employees • Three sections • Monitoring • Data Management • Health Economy, Project Coordination and PROM PROM= patient-reported outcome measurements

  12. Oslo University Hospital • Two special advisers: • GCP • Statistics

  13. Dept. of Research Support and the CTU 2 teams: Biobanking and Reistry Support/ Medinsight 4 statisticians

  14. Research Support at OUH • Facilitate research • Locally • Regionally • Nationally • Provide expert knowledge • Ensure infrastructure for large clinical trials of good quality • Eventually: Provide support for (almost) all stages of the research process from idea to publication

  15. Do you have any questions?

  16. Focus areas – Challenges • Risk management, risk assessment and risk based monitoring • How should we satisfy the requirements of GCP R2? Tolerance limits? Can we do risk assessment in the same way? • On-site monitoring and centralized monitoring • How can monitor and data manager collaborate in an efficient manner?

  17. Focus areas – Challenges cont. • Challenge: Monitor in Trondheim, data manager in Oslo – How to work efficiently? • Regulation 536/2014 on clinical trials on medicinal products and ISO 13485 Medical devices • Increasing interest from the investigators: Do we have all the standard operating procedures that we need? Do we have the knowledge to help the investigator? Need training.

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