What is it? Why is it important?

The Site-Investigator (Site-INV) is responsible for the conduct of a study at a particular study site.

The Site-INV implements the study according to a given study protocol.

With respect to DM responsibilities, the Site-INV:

  • Provides feedback to the SP-INV regarding the implementation of the study database (eCRF) at the study site
  • Delegates data input tasks to qualified and trained local staff (e.g. data handling, data entry, data query management)
  • Ensures data confidentiality by informing the SP-INV regarding changes in local staff (e.g. provide database access to new staff responsible for data entry, remove access from staff leaving the study)

What do I need to do?

When planning a multi-centre study consider recruiting competent local Site-INVs who:

  • Are able to implement required study procedures (e.g. study design, applicable randomisation procedures)
  • Can provide required infrastructure, resources, and disposable free time required for study conduct
  • Have access to competent supporting staff (e.g. data input operator, study coordinator)
  • Have adequate access to target participants providing needed study data
  • Can guarantee correct and timely data entry into the database of the study
  • Can ensure the quality and confidentiality of study data

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 – Professional qualifications of the investigator and projet leader

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.34 Investigator definition
  • 4.0 Investigator qualifications
  • 5.5 Trial Management, data handling, and record-keeping

Swiss Law

ClinO – see in particular article

  • Art. 6 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
Abbreviations
  • CTU – Clinical Trials Unit
  • DM – Data Management
  • eCRF – electronic Case Report Form
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Handling ↦ Stakeholders ↦ Site-Investigator
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): Concept ↦ Data Handling ↦ Stakeholders ↦ Site-Investigator

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