What is it? Why is it important?

Clear requirements exist when evaluating whether a study is ready to start. A study is ready for study-initiation once a study site(s) fulfils all requirements needed for participant recruitment.


Participant recruitment can start when the following criteria are met:

What do I need to do?

As a Site-INV, check that all aspects needed for study start are fulfilled:

  • The site is initiated and prepared for participant recruitment  (e.g. based on a study Site-Initiation-Visit (SIV) organised and coordinated by the SP-INV of the study)
  • Upon SIV, the SP-INV is able to decide whether the site is ready for study conduct. In the event important outstanding issues remain, participant recruitment should be postponed
  • Recruitment can only start when participant safety and the quality of study data can be guaranteed during study conduct


For more information refer to Monitoring and Documents in this Study Guide.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Information on professional qualifications
  • List of persons conducting a study


ICH-GCP E6(R2) – in particular see guidelines

  • 5 Sponsor responsibilities
  • 4 Investigator


ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections

  • 9 Responsibilities of the sponsor
  • 10 Responsibilities of the PI

Swiss Law

HRA – see in particular article

  • Art. 10 Scientific requirements

ClinO – see in particular article

  • Art. 6 Professional qualifications

ClinO-MD – see in particular

  • Art. 5 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • CRO – Contract Research Organisation
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Medical Device
  • ISO – International Organization for Standardization
  • PIS – Participant Information Sheet
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SIV – Site Initiation Visit
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Management ↦ Study Ready for Conduct ↦ Requirements

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
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 Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Set-Up ↦ Management ↦ Study Ready for Conduct ↦ Requirements

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