Course syllabus for Clinical studies and ethics

The course syllabus contains changes
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Course syllabus adopted 2021-02-04 by Head of Programme (or corresponding).

Overview

  • Swedish nameKliniska studier och etik
  • CodeEEN170
  • Credits7.5 Credits
  • OwnerTKMED
  • Education cycleFirst-cycle
  • Main field of studyBiomedical engineering
  • ThemeMTS 3 c
  • DepartmentMEDICIN (GU)
  • GradingTH - Pass with distinction (5), Pass with credit (4), Pass (3), Fail

Course round 1

  • Teaching language Swedish
  • Application code 73116
  • Maximum participants70
  • Open for exchange studentsNo
  • Only students with the course round in the programme overview.

Credit distribution

0121 Written and oral assignments 2.5 c
Grading: TH		 2.5 c
0221 Examination 5 c
Grading: TH		 5 c
  • 12 Mar 2022 pm J
  • 10 Jun 2022 pm J
  • 22 Aug 2022 pm J

In programmes

Examiner

  • Henric Rhedin
Go to coursepage (Opens in new tab)

Eligibility

Information missing

Course specific prerequisites

EEN085 - Medicine for engineers or equivalent is required.

Aim

The purpose of this course is to provide students with basic skills to be able to design clinical trials in biomedical engineering. The course knowledge in clinical trials will include the essential elements for implementation, including time and cost planning, and relate to both the ethical framework and the regulations for medical devices. Students should be able to plan their own fictitious study with suggestions on how requirements in the regulations can be complied with and how the study can be designed from a statistical perspective, with respect to factors like how many patients should be included to meet the required targets.  The course shall contribute to the student’s general understanding how biomedical engineering interacts with society and other scientific disciplines and their norms and attitudes.  

Learning outcomes (after completion of the course the student should be able to)

After concluding the course, the student should be able to:

1.    account for what is required to plan, carry out and complete a clinical trial for biomedical engineering.
2.    analyse, compare and discuss different forms of clinical trials for biomedical engineering regarding design and statistical models.
3.    describe current regulations and guidelines in order to be able to evaluate the various components of a clinical trial for biomedical engineering.
4.    account for the ethical issues that must be taken into account in biomedical engineering clinical trials and which are regulated in the Declaration of Helsinki and the EU regulations for medical devices.
5.    explain the legal conditions that regulate clinical studies in biomedical engineering. 
6.    use relevant databases and regulations for clinical trial within biomedical engineering.
7.    perform a simplified risk analysis to conduct a clinical study of a medical device.
8.    discuss the concept of clinical evidence, publication bias and grey literature in biomedical engineering clinical trials.
9.    account for how the clinical investigation fits into the technical documentation and the clinical evaluation for medical devices.
10.  develop the ability to work effectively in a group.

Content

The course studies in detail how clinical studies are organized, planned and dimensioned. Knowledge from, among other things, the course in mathematical statistics is applied for example dimensioning of clinical trials. Ethical issues and values that are relevant to the design and implementation of clinical trials are addressed. The Declaration of Helsinki and selected parts of the EU regulations for medical devices are reviewed and also contrasted in selected parts with clinical trials for pharmaceuticals. Searches in databases and regulatory sources is performed. The database construction, publication bias and grey literature is explained.  The process of risk analysis and its consequences on the clinical trials are explained and exemplified. Definition of different levels of clinical evidence is reviewed and discussed. The digitalization challenges in the area are highlighted with regard to regulations, ethics and evidence. Project work is included in the form of case studies, where project teams will plan their own fictional clinical study.

Organisation

The responsible department is the Institute of Medicine, Sahlgrenska Academy at Gothenburg University.

The teaching is given in the form of lectures as well as seminars and consultations in small groups. More detailed information is given on the course website before the start of the course.

Literature

Will be published in course memo. Lecture material will complement.

Examination including compulsory elements

The course is examined with a written exam at the end of the course. Group work is examined on a submitted report.

The grading is applied according to the following model; The two examined modules, group work and final written exam, are given points up to 33 points for the group assignment and up to 67 points for the final exam. The added total points gives the final grade in relation to the total points percentage of maximum points (100) according to the scale:

 
>40% grade 3
>60% grade 4
>80% grade 5

Participation in seminars and group work is obligatory.
Detailed information regarding examination will be published on the course homepage before the course starts.


The course examiner may assess individual students in other ways than what is stated above if there are special reasons for doing so, for example if a student has a decision from Chalmers on educational support due to disability.

The course syllabus contains changes

  • Changes to course rounds:
    • 2020-03-18: Examinator Examinator Henric Rhedin (rhenric) added by PA
      [Course round 1]