Course catalogue doctoral education - HT17

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Title Quality assurance of clinical research
Course number 2873
Program 0-Inte del av forskarutbildningsprogram
Language English
Credits 1.5
Date 2017-11-13 -- 2017-11-17
Responsible KI department Institutionen för medicin, Solna
Specific entry requirements
Purpose of the course 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.
Learning outcomes 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
Contents of the course 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.
Teaching and learning activities 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.
Compulsory elements 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.
Literature and other teaching material 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.
Number of students 10 - 25
Selection of students 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).
More information This course is web-based with dedicated time for groupwork, lectures and more. It provides a general introduction to operational conduct in research ethics and how to achieve high quality in scientific work. It is well suited for young researchers in the fields of laborative work, epidemiological research or clinical studies.
Course directors
Earlier evaluation of the course Evaluation report
Course responsible Pierre Lafolie
Institutionen för medicin, Solna
08-51779647
Pierre.Lafolie@ki.se

Klinisk farmakologi
L7:05 Solna
171 76
Stockholm
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