CTU Bern (Clinical Trials Unit)

Writing a clinical trial protocol - essentials for ethics committee submission and research success

Description

The clinical trial protocol is the basis of any clinical investigation and a key factor in the success of the trial. This course aims at conveying participants how to write a clinical trial protocol effectively and in a scientifically sound way. Useful tips for all phases of the protocol development process will be given: from initial research, formal requirements and content-related considerations to the submission to regulatory authorities and eventual protocol amendments. Furthermore, participants will be given the opportunity to put what they have learnt into practice during the writing session on day two.

This course concentrates on the processes of writing and structuring a protocol, using students’ actual planned studies. It is essential that participants are ready to write a protocol i.e. at least an outline/summary of the planned study should be available.

Note that this is not a course on regulatory affairs/the approval process, critical appraisal, or English language and grammar.

Target Audience

  • Principal & Sponsor-Investigators
  • Study coordinators/project managers
  • New and intermediate medical writers


Date 2018

This is a three-day course:

Day one:   Wednesday, 29 Aug 2018, 9:00-16:45 h
Day two:   Thursday, 30 Aug 2018, protocol writing session at home/in your office
Day three: Friday, 31 Aug 2018, 9:00-16:00 h

Costs

Internal participants: CHF 800.- (staff of the Inselspital, Bern University hospital and the University of Bern)
External participants: CHF 1'200.-

Venue

to be announced

Registration

Please register https://www.conftool.com/ctu.