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 study protocol provided by the SP-INV. The Site-INV agrees to comply with its specifications by dating and signing the corresponding protocol version.

 

With respect to Data Management (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 entry tasks to qualified and trained local staff (e.g. data collection, data entry, query management)
  • Verify and confirm that data entered at the site are correct
  • 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 of staff leaving the study team)

What do I need to do?

As a SP-INV planning a multi-centre study, establish a requirement profile of participating Site-INVs who:

  • Are able to implement required study procedures (e.g. visit plan, safety aspects, randomisation procedures)
  • Can provide required infrastructure, resources, and disposable free time required for study conduct
  • Have access to competent supporting staff (e.g. data entry operator, study coordinator)
  • Have access to target participants able to fulfill the study eligibility criteria
  • Can guarantee high quality data and timely data entry into the study database 
  • Can ensure the confidentiality and safety of study participants during study conduct
  • In case of a foreign site, can coordinate protocol submission to local authorities (i.e. international) and get required approvals

Where can I get help?

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

External Links

Swissethics – see in particular

  • Topics/Other Topics/Professional qualifications of the investigator and project leaders of research projects

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
  • 5.6 Investigator selection

Swiss Law

ClinO – see in particular article

  • Art. 6 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
Abbreviations
  • ClinO - Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • DM – Data Management
  • eCRF – electronic Case Report Form
  • HRO - Human Research Ordinance
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Concept ↦ Data Management ↦ Stakeholders ↦ Site-Investigator
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

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
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Concept ↦ Data Management ↦ Stakeholders ↦ Site-Investigator

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