Course catalogue doctoral education - VT21

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Title Quality Assurance of Clinical Research
Course number 2873
Programme 0-Inte del av forskarutbildningsprogram
Language English
Credits 1.5
Notes The course meets the requirements for a general science course.

Date 2020-09-28 -- 2020-10-02
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.
Intended learning outcomes Knowledge and understanding:
Knowledge on how to document data so that all moments in a clinical research process can be re-created in a secured way and valid data generated.
Understand the meaning of the Helsinki Declaration and Good Clinical Practice so that research subjects safety always remain the first priority.
Knowledge in Swedish, European and international legislations, where a project needs to be applied and to which authority, and how such applications are done.

Skills and abilities:
Able to differentiate the responsibilities between the investigator, study team members and sponsor in the clinical trial.
Able to summarise a project proposal into a risk analysis of the project.
Able to use simple statistical tools to judge a project proposal's scientific validity.

Judgement and approach:
Relate to project proposals from the patient perspective including a scientific and sound ethical approach.
Able to judge and critically 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 principles in clinical research and how development of new treatments like medicinal products and medical devices are done. It also explains how safety reporting to authorities is done. It covers laboratory and diagnostic research, and quality assurance in epidemiological and registry-based research. The following laws, regulations and sources are discussed: Act on integrity of personal data (GDPR), 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 This is a blended course that starts with a mandatory face-to-face (F2F) meeting followed by digital training modules. There are two main tracks that run in parallel. The first track is a group work. The second track is based on individual reading of international guidelines in clinical research. The pedagogy is based on the flipped classroom model with readings proposed initially by the faculty, followed by individual and group-based discussions on problems and cases. Proposals for solution are discussed with faculty support. Reading and learning is supported by self-tests. After the first day with a mandatory F2F the rest of the course is provided by internet. There is a mandatory webinar during the course week.
Compulsory elements There is a face-to-face meeting the first day that is mandatory. Each student must participate in a group work. Each student must show activity on the course's home page with a personal introduction, and at least two questions, presentation and/or comments on other students’ postings on each of the nine lectures. Absence or lack of online activity can after the examiner's assessment be compensated by an individually written essay. Webinars are mandatory. To be able to take the final exam all proceding moments must be approved and cleared.
Examination In addition to an approved group work there will be an individual examination with short reply questions.
Literature and other teaching material Recommended literature:
Good clinical practice guide. Medicines and Healthcare Products Regulatory Agency ISBN 978-0-11-7081079.

G3P - Good Privacy Protection Practice in Clinical Research by Karl-Heinz Schriever and Markus Schröder. De Gruyter ISBN 978-3-11-055436-6.

Quick Guide to Good Clinical Practice: How to Meet International Quality Standard in Clinical Research by Cemal Cingi and Nuray Bayar Muluk. Springer ISBN 978-3-319-44343-0.

Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents; Volume 2 by Mindy J. Allport-Settle. PharmaLogika ISBN 978-0-98-2147689.

Some complementary documentation is provided at study start.
Number of students 20 - 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) start date of doctoral studies (priority given to earlier start date)
More information The course is given Monday-Friday. It is difficult to upheld other work simultaneously with the course. Certain moments at campus Solna are mandatory.
Additional course leader Course coordinator is Mari Liljefors.
Latest course evaluation 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
Contact person Mari Liljefors
Institutionen för medicin, Solna

mari.liljefors@ki.se