What is it? Why is it important?

The aim of study feasibility is to evaluate, based on a set of criteria, the likelihood that a study can be conducted, such as:


Assessment of study feasibility is based on information gathered at:


SP-INV level


Site-INV level – as applicable

  • Required infrastructure (e.g. storage facilities with access control, work space, computers, patient rooms, laboratory facilities, handling of biological material)
  • Resources (e.g. expert physician(s), study nurse or coordinator)
  • Availability of target participants (e.g. sufficient number of patients willing to participate)
  • Sufficient time available required to conduct the study 

What do I need to do?

As a SP-INV and Site-INV:

  • Find out how to obtain information on target population at your institution (e.g. number of patients with breast cancer)
  • Be up-to-date on scientific questions pertaining to your study (e.g. scientific publications, expert conferences)
  • Establish and maintain an important network of experts and colleagues
  • Train yourself on setting up a study budget
  • Familiarise yourself with risks as defined by the Swiss law


When planning a study, many potential risks must be taken into consideration.


In the Swiss law risks are defined based on type of study and its intervention:

  • Studies under ClinO
    • Medicinal products: Risk category A, B and C with category C having the highest risk
    • Other clinical trials: Risk category A and B, with category B having the highest risk
  • Studies under ClinO-MD
    • Medical Device: Risk category A and C, with category C having the highest risk
  • Decisions regarding target population
    • Adults, children, adolescents
    • Participants with or without capacity
    • Participants in an emergency situation
  • Type of intervention
    • With or without expected direct benefit
    • With or without minimal risks and burdens


Depending on risk category the required risk management of the study can vary greatly.

Where can I get help?

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


ICH GCP E6(R2) – see in particular guideline

  • 5.0 Quality management

ISO 14155 (access liable to costs) – see in particular section

  • Medical Device

Swiss Law

HRA – see in particular articles

  • Art.16/24 Adults
  • 22 Children
  • 30/31 Emergency

ClinO – see in particular articles

  • Art. 19–22 Risk categorisation of studies with therapeutic and transplant products
  • Art. 61 Risk categorisation other clinical studies

ClinO-MD - see in particular article

  • Art. 6 Categorisation of clinical investigations
  • ClinO – Clinical Trials Ordinance
  • ClinO - MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • 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
  • SP-INV – Sponsor-Investigator
Concept ↦ Quality and Risk ↦ Study Feasibility ↦ 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 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 Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Concept ↦ Quality and Risk ↦ Study Feasibility ↦ Aim

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