VET412 Clinical Research Methodology and Statistics
Showing course contents for the educational year 2016 - 2017 .
ECTS credits: 5
Faculty: Faculty of Veterinary Medicine
Teaching language: EN, NO
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
- 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
- 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
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
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
- 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
- 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.
Attendance is compulsory. An attendence record of at least 75% is required to pass the course.
- Summit and present a trial protocol of an own study
- Written Exam by use of JMP (3 hours)
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