Course code VET412

VET412 Clinical Research Methodology and Statistics

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Showing course contents for the educational year starting in 2015 .

ECTS credits: 5
Faculty: Faculty of Veterinary Medicine and Biosciences
Teaching language: EN, NO
(NO=norsk, EN=Engelsk)
Limits of class size:
20
Teaching exam periods:

Fall week 34-37

Week 34 Aug 22-26th Planning

Week 35 Aug 29-Sept 2nd Individual protocol writing

Week 36 Sept 5th - Sept 9th Statistics

Week 37 Sept 12th - Sept 15th Scientific writing

Course frequency: Annually
First time: 2015V
Course contents:

The following topics will be presented during the course:

Formulating the study aim both in a medical and statistical way, Populations and samples, Randomization and stratification, Designs of Controlled Clinical Trials, Parameters, factors and variables, Study procedure and monitoring, "Good  xxx  Practice¿ [GCP, GLP,GSP GPP,GDMP], Principles of Sample Size Calculation, Ethical demands, Construction of case record forms, Statistical analysis model, Use of JMP software, Presentation of results, Parametric and non-parametric estimation, Non-parametric and parametric ANOVA models, Correlation and Regression Analysis, and Sample size calculation.

Learning outcome:
Through the course the students ae expected to reach the following platforms: To develop and construct trial protocols in CCT, Build a statistical model to answer the aim of the study, and Perform the analysis and present the results.
Learning activities:
The course is a mix of lectures, discussions, assignments, and student presentations.
Syllabus:
The syllabus is mainly based upon a compendium written by the course teacher, Stig Larsen. Some essential books of reference will be suggested during the course.
Prerequisites:
A minimal background in biostatistics (for instance VET410) is required. Some experience with clinical trials is also necessary.
Recommended prerequisites:
Mandatory activity:
Attendance is compulsory. An attendence record of at least 75% is required to pass the course.
Assessment:

The student must submit and present the design of an own study (assignment), and pass a written exam held the last day of the course.

The design assignment following the first week of the course has to be submitted before the second week of lectures begins.

Nominal workload:
125 hours
Entrance requirements:
Open to Ph.D studens at NMBU - Campus Adamstuen.
Type of course:

Lectures and discussions the first week of the course  will focus on the design part. After the first week the student will work on the design and submit this before the second week of lectures. The second week of lectures focuses on statistical analysis of clinical trials.

Fall week 34-37

Week 34 Aug 22-26th Planning

Week 35 Aug 29-Sept 2nd Individual protocol writing

Week 36 Sept 5th - Sept 9th Statistics

Week 37 Sept 12th - Sept 15th Scientific writing

Note:

Deadline for registration: week 28

Examiner:
Examination details: Langsgående vurdering: Bestått / Ikke bestått