Course code VET412

VET412 Clinical Research Methodology and Statistics

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Showing course contents for the educational year 2016 - 2017 .

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

Fall week 34-36

Week 34/35 Planning (At Femunden fjellstue)

Week 36 Individual protocol writing

Week 36 Statistics

Course frequency: Annually
First time: Study year 2015-2016
Last time: 2017H
Course contents:

The following topics are presented during the course:

Part I: Clinical research methodology

- 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 Practice [GCP, GLP,GSP GPP,GDMP]

- Principles of Sample Size Calculation

- Ethical demands

- Construction of Case Record Forms

- Statistical Analysis Model


Part II: Statistical Analysis

- Use of JMP software

- Presentation of results

- Parametric and Non-parametric estimation

- Non-parametric and parametric

- ANOVA models, Correlation and Regression Analysis

- Sample size calculation

Learning outcome:

Through the course the students are expected to reach the following platforms:

- To develop and construct a trial protocols in CCT

- Build a statistical model to answer the aim of the study

- Perform the analysis and present the results

Learning activities:

The course is a mix of lectures, discussions, assignments and student presentations.

- Part I: Lectures and protocol writing of own project

- Part II: Lectures, practical analysis, construction and analysis of own data



Part I:

- Larsen S. Controlled clinical trials, epidemiological studies, basic & laboratory studies, Norwegian School of Veterinary Science 2005

- Pocock SJ. Clinical trials; Wiley & Sons Ltd. 2002.

- Template for CCT trial protocol


Part II:

- Larsen S. Introduction to Medical Statistics, Norwegian School of Veterinary Science 2005.

- Altman DG. Practical Statistics for Medical Research. London, UK: Chapman and Hall; 1990

- JMP/ SAS user manual

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.

Part I:

- Summit and present a trial protocol of an own study

Part II:

- Written Exam by use of JMP (3 hours)

Nominal workload:
130 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.

Deadline for registration: week 29

Course fee: 8500 NOK

Examination details: Langsgående vurdering: Bestått / Ikke bestått