What is it? Why is it important?

Writing a study protocol follows a set of formal structures that include a:

  • Study title
  • Title and signature page
  • Table of content
  • List of abbreviations
  • Synopsis
  • Scientific Content
  • List of references
  • List of appendices


The title and signature page(s) include:

  • The study title
  • Study registration / identification number
  • Name address of the SP-INV (study responsible)
  • Study type (e.g. risk-category, study phase, clinical non-clinical)
  • Name of the investigational product (e.g. IMP/IMD)
  • For a multi-centre study, name and address of participating Site-INVs (site responsible) 


A synopsis, which:

  • Is a brief summary of a planned study, downsized to only one or two pages
  • Provides a better study oversight than a full protocol 
  • Must not contradict the protocol or other study relevant documents (i.e. essential documents)
  • Stands on its own and makes no reference to the full protocol

What do I need to do?

As a SP-INV:

  • Select a protocol template applicable to your study from the swissethics homepage (i.e. templates provide the required formal protocol structures)
  • Name your protocol and ensure the document remains clearly identifiable (e.g. e.g. study code, SP-INV, pharmaceutical company involved, protocol version number, page number, date of release)


When deciding on the protocol title ensure it:

  • Conveys the idea or aim of your study. This will “set the stage” from the very beginning
  • Is different from other or similarly named studies
  • Includes the target population
  • Includes the overall study design
  • Includes relevant keywords needed for search engines to locate the study
  • Is limited to 12 – 15 words (i.e. a good title uses a minimum of words to describe the main study idea)


By including all relevant information, a full study title can be rather long, making referencing difficult. Thus, provide the study with an added but much shorter title, or give it a catchy acronym.  

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 guideline

  • 2.0 Principles of ICH GCP

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”

  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO – International Organization for Standardization
  • SAMW – Schweizerische Akademie der Medizinischen Wissenschaft (Swiss academies of arts and sciences)
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Development ↦ Protocol ↦ Formal Structure ↦ Requirements

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): Development ↦ Protocol ↦ Formal Structure ↦ Requirements

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