What is it? Why is it important?

Swissethics protocol templates comply with protocol writing requirements defined by the Human Research Act (HRA) and its ordinances (ClinO, ClinO-MD, HRO).

 

Swissethics templates:

  • Give a detailed guidance on how to write a study protocol
  • Include all requirements as specified by the law

 

The protocol is the main reference document of a planned study. It must therefore be diligently prepared and provide all information needed to conduct a study.

 

Prior to implementation, the Ethics Committee (EC) and Swissmedic (i.e. risk-category B and C studies) approve the protocol. Once approved, the protocol outlines the rules of the study that must be complied with during study conduct. Thus, instructions must be feasible, clear, and void of unsolicited interpretations.

 

The term Clinical Investigational Plan is synonymous with study protocol, and is used when describing studies involving medical devices. Applicable templates are available on the swissethics homepage.

What do I need to do?

As a SP-INV, access “templates /checklists” on the swissethics homepage and:

  • Access the document “flowchart to assist with the use of the template”. The flowchart will help you select the protocol template applicable to your study. If you cannot find the right template, contact swissethics or one of the seven ethics committees
  • Access the section “Study Protocols”. The document “Requirement for study protocols according to HRA” gives an overview of protocol requirements based on the Swiss law
  • Select the protocol template applicable to your study

 

When writing the protocol ensure:

  • Content is written in a comprehensible manner, including only relevant information
  • Internal inconsistencies are removed
  • All sections are complete
  • The document is identifiable (e.g. document identification)

 

A protocol can also refer to reference documents that provide additional explanatory information, such as an SOP (e.g. participant informed consent procedures, safety assessment)

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

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

 

References

ICH GCP E6(R2) – see in particular guideline

  • 2.0 Principles

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

  • 4 Summary of GCP principles
  • 68 Clinical investigation planning, conduct and termination

SAMW – see in handbook ”Research with Human subjects”

Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • GCP – Good Clinical Practice
  • ISO – International Organization for Standardization
  • SAMW – Schweizerische Akademie der Medizinischen Wissenschaft (Swiss academies of arts and sciences)
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor
Development ↦ Protocol ↦ Formal Structure ↦ Protocol Template
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Protocol ↦ Formal Structure ↦ Protocol Template

Please note: the Easy-GCS tool is currently under construction.