Syllabus database for doctoral courses
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Syllabus database for doctoral courses
SYLLABI FOR DOCTORAL COURSES
Swedish title | Introduktionskurs i kliniska studier: från idé till arkivering |
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English title | Introductory Course in Clinical Studies: From Idea to Archiving |
Course number | 5274 |
Credits | 1.5 |
Notes |
The course meets the requirements for a general science course. |
Responsible KI department | Institutionen för onkologi-patologi |
Specific entry requirements | |
Grading | Passed /Not passed |
Established by | The Committee for Doctoral Education |
Established | 2023-02-22 |
Purpose of the course | 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. |
Intended learning outcomes | 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. |
Contents of the course | - 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 |
Teaching and learning activities | 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. |
Compulsory elements | 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. |
Literature and other teaching material | 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. |
Course responsible |
Elham Hedayati Institutionen för onkologi-patologi elham.hedayati@ki.se Solnavägen 30 J5:30 BioClinicum, Karolinska University Hospital 171 64 Stockholm |
Contact person |
Helen Eriksson Institutionen för onkologi-patologi 08-52482338 073-4025282 helen.eriksson@ki.se BioClinicum J5:30, Solnavägen 30 171 64 Stockholm |