Kurskatalog forskarutbildning - VT24
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| Titel | Quality Assurance of Clinical Research |
|---|---|
| Kursnummer | 5580 |
| Program | 0-Inte del av forskarutbildningsprogram |
| Språk | Engelska |
| Antal högskolepoäng | 1.5 |
| Noteringar |
Kursen uppfyller kraven för en allmänvetenskaplig kurs. |
| Datum | 2022-09-05 -- 2022-09-30 | Kursansvarig institution | Institutionen för medicin, Solna |
| Särskild behörighet | |
| Kursens syfte | This course is suitable for any kind of clinical researcher at KI. The purpose of the course is to carry insights to the participant how to create trustful data, and how to become a trusted researcher. The course brings information of what is required to act safely and in accordance with local rules, national legislation and international treaty's when involved in clinical research. Whether your research is interventional or non-interventional, using quantitative or qualitative methodology, you will after this course know how to act to secure your research persons, your data and your professional career. |
| Kursens lärandemål | Knowledge and understanding:
Conclude which legislations affects clinical research and how they do it. Deduce how clinical research integrity is affected by fabrication, falsification and plagiarism. Account for common problems that may arise in clinical research. Competence and skills: Differentiate the responsibilities between the investigator, the study team members, and the sponsor in a clinical study. Analyse the validity of a research project proposal or publication with a risk-benefit analysis. Translate general research quality systems into own research area. Judgement and approach: Critically identify good clinical scientific practices and deviations from it in clinical research. Judge data validity and their reproducibility. Handling bias, sponsorship, and scientific authorship in a paper. |
| Kursens innehåll | This course presents different quality systems in clinical research including good clinical practice (GCP). In more detail the course also discusses:
How and when the informed consent shall be asked for in relation to the research. Why you can’t substitute research persons. What to consider when constructing a study protocol. How to handle violations to the protocol. Why you need to screen for unwanted effects. What is the responsibility on your shoulders as an investigator? What you can do to safeguard your research and career. |
| Arbetsformer | You should have some basic experience using Canvas as this software is our learning management system. The course is provided in a digital format with video lectures, readings, discussion postings and self-tests. It is divided into two phases. These correspond to one-week full time course distributed over four weeks. The course is self-paced. In the first phase digital lectures are provided on research quality. There are self-tests after each lecture. The first phase includes the GCP course. The second phase lets the student pick an article from a selection of different research areas for an in-depth critical analysis using the analysing tools provided. Finally, the student has to present how quality is applied to, or how it could be incorporated, in the students’ own research area. The faculty is available and on stand-by during the study period (office hours). The study path of each student is monitored. |
| Obligatoriska moment | There will be a mandatory attendance check upon study start. If no-show, the seat will be cancelled and referred to another student on the waiting list for the course. Each self-test must be passed to be considered completed. There is a mandatory multiple choice test to pass halftime into the second phase. To be able to take the final exam all preceding moments must have been cleared. |
| Examination | Having cleared all preceding moments including self-tests and mandatory multiple choice test, an individual final examination with short answer questions is taken. The theme for this refers to implementation of the quality standards in the students own research field. If the final exam is not cleared a new final exam will be offered at next course occasion. |
| Kurslitteratur och övriga läromedel | Recommended literature:
1. Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline. https://ichgcp.net/. Version E6(3) is underway but not yet in force. 2. 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. 3. The European Code of Conduct for Research Integrity. https://allea.org/code-of-conduct/ 4. Good Research Practice. Vetenskapsrådet. https://www.vr.se/english/analysis/reports/our-reports/2017-08-31-good-research-practice.html. A revised version is expected 2023. 5. Science fictions. Stuart Ritchie. Bodley Head, London. ISBN 9781847925657. The course library in the learning management platform Canvas contains several articles and links to relevant sites and will be open during the course for download. |
| Antal studenter | 25 - 35 |
| Urval av studenter | The selection of students will be based on 1) Date for starting doctoral studies 2) Date for half-time. |
| Övrig information | The course is digital, selfpaced and open during 4 weeks. The course uses Canvas, KI learning system. It is good to have some experience of Canvas, or take the students introduction course to Canvas before taken this course. The course content corresponds to 1,5 point (1 week fulltime). (Previous course number was 2873). |
| Ytterligare kursledare | |
| Senaste kursvärdering | Kursvärderingsrapport |
| Kursansvarig |
Pierre Lafolie Institutionen för medicin, Solna 08-51779647 Pierre.Lafolie@ki.se Klinisk farmakologi L7:05 Solna 171 76 Stockholm |
| Kontaktpersoner | - |
