Development of Clinical Trial Protocol
Veterinærhøgskolen Senter for etter- og videreutdanning Controlled Clinical Research Methodology and Statistics: Development of Clinical Trial Protocol Course timetable and location: Part I: October 19th – 23rd at Femund Fjellstue Deadline to deliver finalized protocol: Friday October 30th Part II: November 2nd – 6th at Norwegian University of Life Science, Oslo Exam: Friday November 6th from 09:00 – 13:00 Week 43 & 44 Sunday 19/10 – Friday 23/10 - 2015 Monday 26/10 – Friday 30/10 – 2015 15.00 Departure from Adamstua in private or University cars Sunday 19.00 Arrival Femund Fjellstue 19.30 Dinner 09.00 History of – and processes in Control Clinical Research 10.00 Aim and hypotheses 11.00 Population, selection and sampling 12.00 Monday Lunch 13.00 Work session with own Trial protocol 15.00 Randomisation and Stratification 16.00 Discontinuation from the trial 18.00 Dinner 09.00 Study design overview 10.00 Parallel and stratified design 11.00 Factorial design Working with the trial protocol Veterinærhøgskolen Senter for etter- og videreutdanning Tuesday 12.00 Lunch 13.00 Work session with own Trial protocol 15.00 Latin Square – Multi-cross-over Design 16.00 Semi-Cross over design 18.00 Working with the trial protocol Dinner 09.00 Adaptive and Sequential design 10.00 Response surface design Wednesday 12.00 Lunch Working with the trial protocol 13.00 Work session with own Trial protocol 18.00 Thursday Dinner 09.00 Registration and observations 11.00 Study procedure, monitoring and GCP 12.00 Lunch Working with the trial protocol 13.00 Work session with own Trial protocol 18.00 Dinner 09.00 Data Management and Statistical Model description 10.00 Work session with own Trial protocol Friday 13.00 Working with the trial protocol Lunch 14.00 Departure from Femund Fjellstue Deliver the trial protocol Transportation: The participants will be transported by NVH-cars. In case somebody want to go with own car they have to inform the course responsible person. The total cost of stay at Femund Fjellstue will be covered by the course fee. Veterinærhøgskolen Senter for etter- og videreutdanning Week 45 Monday 2/11 – Friday 6/11 - 2015 09.00 Lecture1: Presentation of results 10.00 Lecture 2: Point and confidence interval presentation 11.00 Lecture 3: Graphic presentation 12.00 Monday Lunch 13.00 Group exercise 15.00 Presentation of group work Tuesday 09.00 Lecture 4: Binomial model 10.00 Lecture 5: Contingency table analysis 12.00 Lunch 13.00 Group exercise 15.00 Presentation of group work Wednesday 09.00 Lecture 6: Analysis of Variance (Parametric) 10.00 Lecture 7: Sample size ; Power Analysis 12.00 Lunch 13.00 Group exercise 15.00 Presentation of group work Thursday 09.00 Lecture 8: Non-parametric analysis of variance 11.00 Lecture 9: Sample size ; Power Analysis 12.00 Lunch 13.00 Group exercise 15.00 Presentation of group work Friday 09.00 Start Exam 13.00 Deliver exam Veterinærhøgskolen Senter for etter- og videreutdanning Course Responsible: Professor Stig Larsen; Faculty of Veterinary Medicine, University of Life Science Oslo Mail address: [email protected] Registration: Administrative responsible: Vibeke Edvardsdal [email protected]. Registration has to be performed via the link http://www.nmbu.no/studier/sevu/kurs/node/23064 Lecturer: Prof Stig Larsen, Ass Prof Petter Mowinckel, Ass Prof Sagita Dewi and PhD-fellow Trond Holand Recommended literature: Pocock SJ. Clinical trials; Wiley & Sons Ltd. 2002. (Please acquire yourself) Larsen S Controlled clinical trials, epidemiological studies, basic & laboratory studies, Development of the study protocol. Course notes for the postgraduate course in research methodology at the Norwegian School of Veterinary Science 2004. (Will be handed out at the course). Template for construction of a CCT trial protocol will be send the participants before the course Accommodation: The first week of the course will take place at Femund Fjellstue. Full pension covers by the course fee. The second week will be performed at the University of Life Science, Adamstua Oslo. Specification of auditorium will be mailed the participants together with other practicalities.
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