Kurskatalog forskarutbildning - VT24
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| Titel | Introductory Course in Clinical Studies: From Idea to Archiving |
|---|---|
| Kursnummer | 5274 |
| Program | 0-Inte del av forskarutbildningsprogram |
| Språk | Engelska |
| Antal högskolepoäng | 1.5 |
| Noteringar |
Kursen uppfyller kraven för en allmänvetenskaplig kurs. |
| Datum | 2023-10-02 -- 2023-10-06 | Kursansvarig institution | Institutionen för onkologi-patologi |
| Särskild behörighet | |
| Kursens syfte | The purpose of the course is to give the participants a practical understanding and insight into the process, principles and rules within the start-up, implementation and completion of clinical studies. |
| Kursens lärandemål | After the course, the doctoral student is expected to:
- be able to plan and develop a study protocol including a thorough methodical evaluation and selection of an appropriate study design. - be familiar with the various regulations surrounding a clinical study (Declaration of Helsinki, Ethical Review Act, EU Regulation 536/2014 CTR, Data Protection Regulation GDPR, etc.) and based on these be able to plan, carry out and end a clinical study in the right way. - know the various agreements required at start-up, of a clinical study. - be able to reflect critically on other students' research projects in a scientifically constructive way. |
| Kursens innehåll | - Review of the study process /study planning
- Writing study protocols - Statistics and method review Study implementation (data collection, journal entries, safety reporting, etc.) - Review of different concepts and actors in clinical studies (incl. medical technology and IVDR) - Lectures on Good Clinical Practice (GCP), Declaration of Helsinki and other regulations - Applications (Ethical Review Authority, Medical Products Agency, Biobank) - Ethics in research based on regulations (Declaration of Helsinki, Ethical Review Act, CTR, etc.); to weigh risk against benefit, to write a patient information consent, the consent process, etc., - Agreement/cost calculation - Closing/Archiving/Reporting |
| Arbetsformer | Lectures from authorities and people specialised in their respective fields, group exercises, seminars and oral and written presentations. The course focuses on practical learning by translating knowledge in a practical sense and critical reflection of ability. |
| Obligatoriska moment | Compulsory attendance at lectures, group exercises and presentations. Absences are made up for at a later course after consultation with the course coordinator. |
| Examination | To pass the course, the student must demonstrate that the intended learning outcomes have been achieved. This is assessed through active participation in seminars and approved oral and written presentation.
Participants will be divided into smaller groups. The aim is to review the study protocols within each group, critically analyse the content, and give feedback to each other. Participants will complete several assignments throughout the course, which will aid their ability to write a study protocol. Certificates in GCP are included for those who pass. |
| Kurslitteratur och övriga läromedel | Recommended course literature:
- Declaration of Helsinki - ICH GCP, The International Council for Harmonization, Guideline for Good Clinical Practice (E6),R2 - Act on ethical review of research (2003:460) - Clinical Trials Regulation EU, 536/2014 - Biobank Act - Clinical Studies Sweden During the lectures will also be referred to other applicable laws and regulations. |
| Antal studenter | 10 - 15 |
| 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) start date of doctoral studies (priority given to earlier start date) |
| Övrig information | The course is given for one week at Karolinska University Hospital in Solna. |
| Ytterligare kursledare | Helene Sjöö helene.sjoo@regionstockholm.se Klinisk Prövningsledare, Utbildningssamordnare, Karolinska Trail Alliance (KTA) |
| Senaste kursvärdering | Kursvärderingsrapport |
| Kursansvarig |
Elham Hedayati Institutionen för onkologi-patologi elham.hedayati@ki.se Solnavägen 30 J5:30 BioClinicum, Karolinska University Hospital 171 64 Stockholm |
| Kontaktpersoner |
Helen Eriksson Institutionen för onkologi-patologi 08-52482338 helen.eriksson@ki.se BioClinicum J5:30, Solnavägen 30 171 64 Stockholm |
