Kurskatalog forskarutbildning - HT18

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Titel Quality assurance of clinical research
Kursnummer 2873
Program 0-Inte del av forskarutbildningsprogram
Språk Engelska
Antal högskolepoäng 1.5
Noteringar Kursen uppfyller kraven för en allmänvetenskaplig kurs.

Datum 2018-10-22 -- 2018-10-26
Kursansvarig institution Institutionen för medicin, Solna
Särskild behörighet
Kursens syfte This course provides the participant with the knowledge needed to secure the quality in clinical research. It gives an understanding of what is required to act safely and in accordance with local and national legislation, ethical guidelines and international treaty's when involved in clinical research. The course is useful for those working with translational or clinical laboratory research. It is valuable for researchers working with patient quality registries, other types of health registries and in epidemiology. It gives great value to researchers concerned with interventional studies including medicinal products, surgical treatments or pharmaceutical treatments. Beyond the competence you will get, you can also take a test for an internationally recognized certificate in ICH-GCP (International Conference of Harmonisation - Good Clinical Practice). Regardless of your research area, you will after this course understand how to protect patient's safety, and how to create trustful data.
Kursens lärandemål Knowledge and understanding
Knowledge on how to document data so all moments in a clinical research process can be recreated in a secured way
Understand the meaning of the Helsinki Decaration and Good Clinical Practice so that research subjects autonomy and integrity always remain the first priority
Knowledge on Swedish, European and international legislations, on which projects that need to be applied for and to which authority, and how such applications are done

Skills and abilities
Able to decide what different responsabilities the investigator, study team members and sponsor has in the clinical trial
Able to summarise a project proposal into a synopsis and based on that make a risk-benefit analysis of the project
Able to use simple statistical tools to judge a project proposal's scientific validity

Judgement and approach
Able to judge project proposals from the patient perspective including a scientific and sound ethical approach
Able to evaluate information from different internet database sources
Kursens innehåll The course provides insights into research ethics, and how applications to different authorities are done, it presents how clinical trials are undertaken, and how development of new treatments, in particular medicinal products, are done, and how safety reporting to authorities is done. The following laws, regulations and sources are discussed: Act on integrity of personal data, Act on ethical review of research projects, Act on biobanking, Act on patient data in health care, Act on archiving, and international registry's on clinical research. Risk analysis and some statistics are discussed.
Arbetsformer The course is based on e-learning. There are two tracks, in part parallel. One track is based on group work around cases that are presented to the course. The other track is based on individual studies of GCP regulations. Both tracks include study material and tutor support. The pedagogy is based on flipped classroom meaning that instructions and learning resources will be made available early to support the individual learning and group works. Cases and their solutions will be presented and discussed under teachers supervision. Q&A will be provided. The GCP studies will be supported by MC self tests. Webinars may be provided, pending the need from the course.
Obligatoriska moment Each student must participate in a group work. Each student must show activity on the course's home page with at least five questions, presentation and/or comments on others postings. Absence or lack of online activity can after the examiner's assessment be compensated by an individually written essay.
Examination In addition to an approved group work there will be an individual multiple choice examination.
Kurslitteratur och övriga läromedel Recommended literature: Good Clinical Practice. Medicines and Healthcare Products Regulatory Agency, UK, 2012. ISBN 978-0-11-7081079. Links and some other documentation will be handed out at the start of the course.
Antal studenter 20 - 25
Urval av studenter Selection will be based on 1) the relevance of the course syllabus for the applicant's doctoral project (according to written motivation), 2) date for registration as a doctoral student (priority given to earlier registration date)
Övrig information The course is provided in English. It is a blended course, with a major part of the course done in KI's learning management system. Physcial attendance is needed the first morning 9-12 at KI campus in Solna. The course starts with a group-work. There is also a live webinar late Wednesday evening. The course is flipped, meaning that a major part of the the students work is supposed to be done on your own, supported by the course materials. Mutual time will be devoted to provide feedback, and outlooks. The course is demanding in terms of activities. Beyond the course examination students will be offered a possibility to sit an examn for a GCP certificate.
Ytterligare kursledare Mari Liljefors
Tidigare omdöme av kursen omdöme
Kursansvarig Pierre Lafolie
Institutionen för medicin, Solna
08-51779647
Pierre.Lafolie@ki.se

Klinisk farmakologi
L7:05 Solna
171 76
Stockholm
Kontaktpersoner Mari Liljefors
Institutionen för medicin, Solna

mari.liljefors@ki.se