CTU Bern (Clinical Trials Unit)

CTU Templates

All works such as templates, work instructions and user manuals are created and
authored by CTU Bern. These works are under the Creative Commons Attribution 4.0
International License.
Partner may reproduce, distribute and make publicly accessible the work. Partner must include the name of CTU Bern, the title of the work, its sources, and this license CC-BY 4.0.
To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

Study development

Clinical protocol template for IIT (Investigator-Initiated Trials) studies

Template: See current version on swissethics website

Checklist for protocol review

CV Investigator

This is a template for the CV which needs to be handed in for the KEK inspection.


Study conduct

Trial Master and Investigator Site File

Site Delegation Log

Subject Prescreening Log

Subject Screening, Enrolment, Identification Log

Subject Enrolment Identification Log

Subject Log

Source Data Location List

Note To File

Temperature Log

Form to record Adverse Events

Form to record and report Serious Adverse Events


Study completion

Dataset for statistical analysis