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Education and Training Requirements for Monitors in Clinical Trials in Sweden

This document provides an overview of the necessary education and training for monitors in academic clinical trials, specifically in Sweden. It outlines the requirements based on ICH-GCP guidelines, emphasizing the need for monitors to possess scientific knowledge and familiarity with investigational products, protocols, and applicable regulations. The Swedish Academy of Pharmaceutical Sciences offers various programs such as diplomas and certifications in clinical trials monitoring. Regional and local educational opportunities include courses in GCP and monitoring, enabling professionals to develop their skills effectively.

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Education and Training Requirements for Monitors in Clinical Trials in Sweden

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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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