What is it? Why is it important?

The aim of a study or research protocol is to provide a detailed description of a planned study or research project.


Descriptions include the:


Prior to implementation, the protocol is reviewed and approved by the Ethics Committee (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 specifications are complied with during study / project conduct.


Important incentives of having a well-defined protocol would be to:

  • Convince others of the value and importance of one´s study or research project
  • Provide transparency with standardize methods allowing for a successful replication by other researchers
  • Facilitate the assessment of study results through peer reviews (evaluation by persons with same competence)

What do I need to do?

As a SP-INV or project leader, you are responsible for the write up of the study / research protocol, describing what you want to do, 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, a research project under HRO)


When writing a protocol:

  • Only use templates that have been approved by swissethics
  • 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 (e.g. statistician, monitor, data manager, regulatory expert)


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


Protocol deviations during study conduct must be handled by a SP-INV or project leader without delay.

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



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

HRO – see in particular article

  • Art. 5 Storage of health-related data and biological material
  • Art. 7 Categorisation
  • Art. 18 Changes
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • GCP – Good Clinical Practice
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor Investigator
  • WI – Working Instructions
Basic ↦ Protocol ↦ Study Protocol ↦ Aim

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Basic ↦ Protocol ↦ Study Protocol ↦ Aim

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