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E ducation and training of monitors in academic clinical trials

E ducation and training of monitors in academic clinical trials. Maria Skoog Clinical Studies Sweden – Forum South Clinical study support Skåne Universityhospital, Lund. What are the requirements :. ICH–GCP: Monitors should: be appropriately trained

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E ducation and training of monitors in academic clinical trials

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  1. Education and trainingofmonitors in academicclinicaltrials Maria Skoog Clinical Studies Sweden – Forum South Clinical study support Skåne Universityhospital, Lund NORM 17-09-2019

  2. Whatare the requirements: ICH–GCP: Monitors should: • be appropriately trained • have the scientific and/or clinical knowledge needed • be thoroughly familiar with the investigational product(s), the protocol, written informed consent form, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s) Swedish Medical Products Agency: Monitor should: • be independent of the actual study • have knowledge of GCP and monitoring. NORM 17-09-2019

  3. Whateducation and training is available? National / Independent organisations Regionally / Locally NORM 17-09-2019

  4. National / Independent organisations Swedish Academy ofPharmaceutical Sciences (Läkemedelsakademin) Between 1994-2017 theyexecuted • Diploma in Clinical trials (app. 150 executed) Between2012-2017theyexecuted • Certification in monitoringofclinicaltrials (app.50 executed) NORM 17-09-2019

  5. National / Independent organisations Swedish Academy ofPharmaceutical Sciences (Läkemedelsakademin): • Monitoring ofInvestigatorinitiated studies (2 day) • Sponsors QualityAssurance – Clinical studies - Complementarycourse (2 day) Certificateofattendance NORM 17-09-2019

  6. Regional / LocalEducation Certificateofattendance • GCP-course (1-3 day - basiclevel, advancedlevel, refrescher) • Course in monitoring (2 day - basiclevel) Uppsala Clinical Research Center • Youcanattend a regional/localcourseregardlessofyourown regional belonging. NORM 17-09-2019

  7. Regional / LocalEducation Credits (highereducationpoints) – Univertitycourses • 7,5 credits (5 weeks) • Quality work in clinical research and clinical trials, Lund • Clinical trial Advanced level, Gothenburg • 15 credits (10 weeks) • Clinical research and trial in practice, Örebro • 30 credits (20 weeks/1 term) • Clinial Drug Development, Uppsala NORM 17-09-2019

  8. Regional / Localtraining • Training in the workplace by mentoring • Comonitor, with a moreexperiencedcollague/ walking beside  Learnby dooing NORM 17-09-2019

  9. Thankyou! NORM 17-09-2019

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