Your Easy Guide to Clinical Studies

The study protocol, also named the Clinical Investigation Plan (CIP) for studies with Medical Devices, is the core document that:

• Describes the scientific background and rationale of the study, the study objective(s), hypothesis, outcome(s) / endpoint(s), the study design, the planned statistical analysis / method(s), and applicable safety considerations.
• Defines the procedures and requirements for study conduct that all study personnel and participants must comply with

 

The protocol/CIP synopsis is a concise summary of the main protocol/CIP and serves as a road map or panoramic view of the planned study.

 

Because study protocols/CIPs are often lengthy documents, the synopsis is frequently used when applying for funding, requesting institutional support, or providing an overview to collaborators.

 

Swissethics strongly recommends the use of its protocol/CIP templates. The appropriate template depends on the type of study (ClinO, ClinO-MD, Other Clinical Studies, HRO)

As a SP-INV:

• Select the appropriate swissethics protocol/CIP template for your study. The templates provide detailed guidance on required content and structure
• Identify and involve experts in developing the protocol/CIP, such as a statistician, project manager, quality manager, data manager, regulatory affairs specialist, or experienced study nurse

 

When developing the study protocol/CIP:

• Clearly define the study objective(s), research question(s) and hypothesis
• Specify relevant, feasible, and measurable study outcome(s) / endpoint(s)
• Develop an appropriate statistical analysis plan, including a justified sample size calculation where applicable
• Select a study design that is fit-for-purpose while avoiding unnecessary complexity
• Describe measures to protect the rights, safety, and well-being of study participants
• Define procedures to ensure data integrity and data quality
• Before finalizing the protocol/CIP, verify that the protocol synopsis is fully consistent with the main text of the protocol

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 E8(R1) – see in particular guidelines:

• 2.2 Scientific approach to study planning and implementation

ISO 14155:2026 Medical devices - see in particular sections (access liable to cost)

• 3.10 Clinical Investigation Plan definition
• 6.4 Clinical Investigational Plan 
• 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