What is it? Why is it important?

Clear requirements exist when evaluating whether a study is ready for initiation. Study conduct is initiated once the study can actively start to recruit participants.

Participant recruitment can start when the following criteria are met:

  • Study is EC and if applicable also RA approved
  • Study is registered
  • Contracts with partners/vendors are finalised and signed (e.g. insurance for liability coverage, contract with CRO)
  • IMP/MD is labelled and delivered to the study site
  • Essential documents are completed and filed
  • Additional documents are ready for use (e.g. PIS, ICF, screening log, patient identification log)

What do I need to do?

Check that all aspects needed for study start are fulfilled:

  • The site is initiated and prepared for participant recruitment at the SIV
  • Upon SIV the SP-INV is able to decide whether the site is ready for study conduct
  • In the event 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 – in particular see

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

References

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

  • 5. Sponsor responsibilities
  • 4. Investigator

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

  • 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

HRO – see in particular article

  • Art. 4 Professional qualifications
Abbreviations
  • CTU – Clinical Trials Unit
  • CRO – Contract Research Organisation
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD - Investigational Medicinal Product / Medical Device
  • ICF – Informed Consent Form
  • ISO – International Organization for Standardization
  • PIS – Participant Information Sheet
  • RA – Regulatory Authorities
  • SIV – Site Initiation Visit
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Set-Up ↦ Management ↦ Study Ready for Conduct ↦ Requirements
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

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

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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