CTU Bern

The clinical study protocol basics

The University Executive Board has taken the decision that all activities that take place within the framework of the university, with the exception of teaching at Bachelor and Master level, will be subject to a Covid certificate requirement as of Wednesday, September 1. Therefore, starting September 1st, all participants of on-site CTU courses will have to bring a valid Covid certificate (on the day of the course) together with an official ID in order to participate in the course.

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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, 8 October 2021, 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)
External participants: CHF 250.-

Venue

CTU Bern, Mittelstrasse 43, 3012 Bern, room 320

Course flyer

The clinical study protocol basics course (PDF, 66KB)