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 2017

This is a three-day course:

Day one:   Wednesday, 8 Nov 2017, 9:00-16:45 h

Day two:   Thursday, 9 Nov 2017

                  protocol writing session at home/in your office

Day three: Friday, 10 Nov 2017, 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

Institute of Social and Preventive Medicine (ISPM)
Seminar room 606, 1st floor
Finkenhubelweg 11, 3012 Bern 

Registration

Please register online: www.kas.unibe.ch/ctu

 

Date 2018

This is a three-day course:

Day one:   Wednesday, 7 Nov 2018, 9:00-16:45 h

Day two:   Thursday, 8 Nov 2018

                protocol writing session at home/in your office

Day three: Friday, 9 Nov 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.