FINLAND Leena Partanen Study Monitor

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Presentation transcript:

FINLAND Leena Partanen Study Monitor Clinical Research Institute HUCH Ltd NORM Meeting Copenhagen 25.9.2018

Organisation of Academic Monitoring Area 338 424 km² 5,5 million inhabitants 5 University Hospitals Main responsibility for monitoring of academic trials In addition freelancers and private companies

Helsinki University Hospital Clinical Research Institute HUCH Ltd Fully owned by Helsinki and Uusimaa Hospital district In addition few trials monitored by freelancers 1,5 monitors for academic trials One part timer Plans & Agreements, invoices 43 academic trials 27 on going, 7 about to start, 9 in process Majority cancer trials Trials monitored in all university areas Majority in Helsinki University Hospital

Tampere University Hospital 3 monitors 1 full time, 1 half time and 1 part time 30 academic trials monitored 53 sites Trials monitored in all university areas Several multinational studies

Turku University Hospital Turku Clinical Research Centre (TurkuCRC) 1 monitor with also other responsibilities Other professionals monitoring randomly Currently 8 academic trials monitored Operating mainly in Turku

Kuopio University Hospital Own monitoring activities are being initiated 1 monitor in training Currently monitoring of academic trials is carried out by monitors of the other University Hospitals or private companies Since monitoring of academic trials is organised by investigators themselves, precise numbers of monitored academic trials are not available

Oulu University Hospital 1 study coordinator who is responsible also for monitoring Other responsibilities include new CTAs and invoicing Also acting as a study nurse in a few trials Currently 8 trials monitored All monitored trials in Oulu University Hospital In addition some trials monitored by private companies Plans to start a centralized research unit Currently medical spesiality areas are operating quite independently in organizing their research projects

Current Topics Development: Challenges: Strengthening the national monitoring network and cooperation Monitoring education 2017 Updating the common shared monitoring tools and templates Development of research units and monitoring inside university hospitals Challenges: Budgeting: Monitoring is payed by the investigators Increasing amount of monitored trials due to increasing awareness of the need of monitoring Increasing amount of more complicated multinational, multicenter trials Implementation of GDPR