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

 

By approving and signing the study protocol, the SP-INV, including any participating Site-INV(s) and other potential signees (e.g. statistician) confirm their commitment to conduct the study according to:

• Specifications given in the protocol
• The Declaration of Helsinki
• If applicable ICH-GCP guidelines
• ISO 14155 for studies with medical device
• The Swiss law (e.g. data protection laws, HRA, ClinO, ClinO-MD, HRO)

 

A protocol must have clearly marked identifiers (e.g. protocol version number, release date). In the event of protocol changes or amendments, requires that identifiers are adapted accordingly. This is important as the Ethics Committee (ECs) or RAs (e.g. Swissmedic) who approve study protocols, do this on the basis of a particular protocol version.

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As a SP-INV:

• Select and download the official protocol template applicable to your study from the swissethics webpage. The template ensures compliance with the formal protocol structure, and provides comprehensive guidance on required protocol content
• Fill in all required study information (e.g. research question, study design, statstical analysis plan, safety issues)
• Include reviews by applicable experts who contribute to its content (e.g. statistician, quality-, project-, data manager, study nurse)
• Consider to have the protocol reviewed by an impartial expert who can provide important professional support
• Place the synopsis at the beginning of the protocol

 

Invest sufficient time in protocol development, as a well prepared and thought through protocol will:

• Avoid unexpected difficulties, requiring protocol amendments due to protocol inconsistencies during study conduct
• Save not only resources and costs, but also the required time needed to complete the study (e.g. amendments are costly and may delay the study)

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
• Art. 29 Changes

ClinO-MD - see in particular articles

• Art. 6 Categorisation
• Art. 15 Changes

HRO – see in particular articles

• Art. 7 Categorisation
• Art. 18 Changes