CTU Bern (Clinical Trials Unit)

CTU Templates

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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