Your Easy Guide to Clinical Studies

The aim of a study protocol, also referred to as a Clinical Investigational Plan in Medical Device studies, is to provide a detailed description of a planned study or research project.

 

Descriptions include the:

• Background and rational of the study
• Research question (e.g. study hypothesis, study outcome / endpoint, expected benefit)
• Study design (e.g. methodology, randomisation, intervention and control group)
• Study population (e.g. population descriptive)
• Safety considerations (e.g. study risk-benefit-ratio)
• Statistical analysis plan
• Authorities (e.g. Ethics Committee (EC), Swissmedic, FOPH, international authorities), laws (e.g. HRA, HRO, ClinO, ClinO-MD, data protection act), and regulations (e.g. ICH-GCP, ISO 14155, ISO 20916) under which a study will be conducted
• Data confidentiality (i.e. storage of health related data and biological material)
• Quality aspects (e.g. SOPs, WIs)

 

Prior to implementation, the protocol/CIP is reviewed and approved by the EC, and if applicable other regulatory authorities (e.g. Swissmedic (risk-category B and C), FOPH or international).

Once approved, the SP-INV, Site-INV, and project leader must ensure protocol / CIP specifications are complied with during study / project conduct.

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As a SP-INV or project leader, you are responsible for the write up of the study protocol/CIP. You describe what you want to do in the study, why you want to do it, and how you plan to do it.

 

Based on your study or research project, access the swissethics homepage and select the applicable template (e.g. an interventional study under ClinO, ClinO-MD, and a research project under HRO)

 

When writing a protocol/CIP:

• Only use templates that have been approved by swissethics. For international studies, different protocol templates may apply (i.e. refer to the Swiss protocol appendix to cover Swiss requirements)
• Preferably use the English language in order to reach an international audience
• Select qualified staff to support you in the write-up of the protocol/ICIP (e.g. statistician, monitor, data manager, regulatory expert)

 

Changes to an already approved protocol/CIP require the submission of a protocol/CIP amendment and approval by EC and as applicable Swissmedic.

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External Links

Swissethics – see in particular

• Templates / Checklists / “Flowchart to assist with the use of the template”
• Templates / Checklists / Study protocols / Requirement for study protocols according to HRA

SPIRIT – see in particular

• SPIRIT Statement
• Checklist

References

ICH GCP E6(R2) – see in particular  guidelines

• 1.44 Protocol definition
• 1.45 Protocol Amendment
• 6 Clinical trial protocol and protocol amendment(s)

ISO 14155:2020 Medical device (access liable to cost) – see in particular sections

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

Declaration of Helsinki – see in particular principles

• 21-22 Protocol requirements

Swiss Law

HRA – see in particular articles

• Art. 5 Scientifically relevant topic
• Art. 10 Scientific requirements
• Art. 11 Protection of participants / Subsidiarity
• Art 12 Protection of participants / Risks and burdens
• Art. 15 Safety and protective measures

ClinO – see in particular articles

• Art. 5 Rules of Good Clinical Practice
• Art. 18 Storage of health-related data and biological material
• Art. 19, 20, 49, and 61 Categorisation 
• Art. 29, 34, 55 Changes

ClinO-MD – see in particular article

• Art. 6 Categorisation of clinical investigations
• Art. 15 Modifications

HRO – see in particular article

• Art. 5 Storage of health-related data and biological material
• Art. 7 Categorisation
• Art. 18 Changes