Your Easy Guide to Clinical Studies

The study protocol is the core document that:

• Describes the study background, objective(s) / hypothesis, outcome(s) / endpoint(s), study design, statistical method(s), including applicable safety aspects
• Lays down the rules for study conduct, that must be complies with by study staff and study participants

 

The protocol synopsis is a short summary of the protocol and provides a kind of roadmap or panoramic view of the planned study.

The protocol is often an extensive document. As a result, the synopsis is often presented when applying for grants or seeking other types of support.

 

Swissethics provides a selection of mandatory protocol templates. Which template to use depends on study:

• Type, such as ClinO, ClinO-MD studies, or Other Clinical Studies and HRO studies
• Risk-Category (i.e. with A low-, B intermediate-, and C high-risk studies)

As a SP-INV:

• Start by selecting the applicable protocol template provided by swissethics. The template ensures compliance with thel formal protocol structure, and provides comprehensive guidance on required protocol content
• Consider what additional support or expertise must be recruited for the protocol write-up (e.g. a study statistician, quality-, project-, data manager, an experienced study nurse)

 

Aspects to consider when writing your synopsis and study protocol, include to:

• Define the research question(s) / hypothesis of your study
• Decide on achievable and measurable study outcome(s) / endpoint(s)
• Define the statistical analysis plan. The plan includes the sample size calculation that defines the required number of participants needed to answer your research question(s)
• Choose a fit for purpose study design, while avoiding unnecessary complexity
• Define how study participant rights and safety can be protected
• Define how data quality can be guaranteed

External Links

Swissethics – see in particular

• Broad selection of protocol templates

References

ICH GCP E6(R3) – see in particular

• 1.44 Glossary: Protocol definition
• Appendix B. Clinical trial protocol and protocol amendment(s)

ICH GCP E8(R1) – see in particular guidelines:

• 2.2 Scientific approach to study planning and implementation

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

• 6.4 Clinical Investigational Plan (CIP)
• Annex A CIP

Declaration of Helsinki – see in particular principles

• 21 – 22 Protocol requirements

Swiss Law

ClinO – see in particular articles

• Art. 19, 20, 49 and 61 Categorisation

ClinO-MD - see in particular

• Art. 6 Categorisation of clinical trials

HRO – see in particular articles

• Art. 7 Categorisation