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.

More

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

 

Ensure your study:

• Is described in a clear, concise and operationally feasible protocol.
• Is designed in such a way as to;
  • Minimize unnecessary complexity
  • Mitigate or eliminate risks to the rights, safety, and well-being of study participants
  • Ensure the quality of your study data

 

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)

More

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(R3) – see in particular  guidelines

• 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 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