Introductory Course in Clinial Studies: From Idea to Archiving

Third-cycle level | 1.5 credits (HEC) | Course code: K7F5274
HT 2024
Study period: 2024-09-30 - 2024-10-04
LANGUAGE OF INSTRUCTION: The course is given alternately in Swedish and English
Application period: 2024-04-15 - 2024-05-06
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Course description

This doctoral course is designed for students seeking comprehensive practical knowledge in conducting clinical studies, with included certificates in Good Clinical Practice (GCP) for successful participants.

Course Objectives: The course aims to provide participants with a practical understanding and insight into the processes, principles, and regulations involved in the initiation, implementation, and completion of clinical studies.

Upon Completion of the Course, Doctoral Students Will:

Plan and Develop a Study Protocol: Gain the ability to plan and develop a study protocol, demonstrating a thorough and methodical evaluation for selecting an appropriate study design.

Navigate Regulatory Frameworks: Acquire familiarity with various regulations governing clinical studies (Declaration of Helsinki, Ethical Review Act, EU Regulation 536/2014 CTR, Data Protection Regulation GDPR, etc.) and demonstrate the ability to plan, execute, and conclude a clinical study in compliance with these regulations.

Understand Required Agreements: Acquire knowledge of the various agreements necessary during the initiation of a clinical study.

Critically Reflect on Research Projects: Develop the ability to critically reflect on fellow students' research projects in a scientifically constructive manner.

Join us to enhance your skills and knowledge in clinical study conduct and earn a valuable GCP certificate upon successful course completion.

Apply now to embark on a journey towards becoming an adept clinical researcher!

Requirements and Selection

Prerequisite courses, or equivalent

No prerequisite courses, or equivalent, demanded for this course. 

Selection

The selection is based on 1) the relevance of the syllabus to the applicant's research project (according to motivation), 2) the start date for doctoral studies (where earlier dates have priority).

Course director

Elham.Hedyati@ki.se

 

helene.sjoo@regionstockholm.se Klinisk Prövningsledare, Utbildningssamordnare, Karolinska Trail Alliance (KTA)

Course syllabus

K7F5274

Department

Department of Oncology-Pathology

Doctoral programme

**Not within a doctoral programme

Type of course

Quality Assurance of Clinical Research

Keywords

Clinical studies, Good Clinical Practice (GCP), Study protocol, Study design, Regulatory frameworks, EU Regulation 536/2014 CTR, Clinical researcher

CONTACTHelen Eriksson

helen.eriksson@ki.se