1 / 17

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 )

cbolivar
Télécharger la présentation

Monitoring in Norway

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related