The clinical study protocol basics
Update 17.02.22 The Federal Council and the Canton of Bern have decided that almost all protective measures are lifted with immediate effect. For our courses, this means in particular that the obligation to wear masks indoors and the obligation to obtain a certificate will no longer apply.
Despite the lifting of the protective measures, the coronavirus is still with us. We therefore appeal to your personal responsibility to show consideration for one another and continue to adhere to the hygiene rules which have been established.
The study protocol is the basis of any clinical investigation and a key factor in the success of the trial. This half-day course is a very condensed version of the former Writing a clinical trial protocol course. The importance of the protocol as the central document for a study will be discussed and essential elements for the most important chapters will be presented. Connections between chapters and elements will be highlighted with a special focus on the importance of consistency within the document. In a small group work we will critically appraise and discuss a real protocol of a randomized-controlled trial.
Note that this is not a course on regulatory affairs/the approval process or English language and grammar.
Target Audience
- Principal & Sponsor-Investigators
- Study coordinators/project managers
Dates
This is a half-day course:
- Friday, 2 September 2022, 13:00-17:00 h
Number of participants: minimum 6
Please register for the courses 2021 with your credit card here.
Costs
Internal participants: CHF 30.- (staff of the Inselspital, Bern University hospital and the University of Bern and students enrolled at the University of Bern)
External participants: CHF 250.-
Venue
CTU Bern, Mittelstrasse 43, 3012 Bern, room 320
Course flyer