What is it? Why is it important?

The Site-Investigator (Site-INV) has the main responsibility for a particular study-site, where the study of the SP-INV is implemented. Study responsibilities range from set-up until completion, including archiving.


Responsibilities include to:



If at a particular site, the study is conducted by a team of individuals, the Site-INV would be the responsible leader of the team. Thus, in these instances the Site-INV will be given the title Principal Investigator.

What do I need to do?

As a Site-INV:

  • Familiarize yourself with Site-INV responsibilities
  • Retain ongoing oversight of local study activities including any delegated tasks
  • Attend GCP training courses for the use of  Investigational Medicinal Product (IMP) (e.g. ClinO studies)
  • Have ISO 14155 training for the use of Investigational Medical Device (IMD) (e.g. ClinO-MD studies)
  • Have ISO 20916 training for the use of in vitro medical device studies
  • Exercise the applicable medical profession and have the professional knowledge and scientific expertise for the planned study. In the event a medical profession is not required (e.g. Other Clinical Studies, research projects under the HRO ordinance), exercise the study applicable non-medical profession


Based on your planned study, as a Site-INV you must also comply with:


Depending on whether you are a Site-INV or the SP-INV of the study, will greatly affect study obligations and responsibilities.


During study conduct, the Site-INV is responsible to:

  • Implement the study according to the current study protocol
  • Recruit study participants, explain the conduct and aim of the study and sign the ICF together with the participant
  • Ensure the recruitment of study participants comply with any predefined timelines
  • Protect the rights, safety and well-being of study participants (e.g. participant risk-benefit)
  • Ensure study design and randomisation procedures are correctly followed
  • Guarantee the quality and integrity of study data collected at the study site
  • Follow and ensure risk control measures are implemented and effective
  • Forward safety issues to the SP-INV within required timelines
  • Handle IMP/IMD according to SP-INV specifications
  • Manage study document with ongoing filing of essential documents (e.g. ISF)
  • Supervise delegated study-related tasks

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) – see in particular guidelines

  • 1.34 Investigator definition
  • 4 Site-INV responsibilities

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

  • 3.30 Investigator definition (Site-INV)
  • 3.39 Principal investigator definition (Site-INV)
  • 10 Responsibilities of the principal investigator (Site-INV)

Swiss Law

ClinO – see in particular articles

  • Art. 2 Definitions
  • Art. 6 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
  • EC – Ethics Committe
  • FOPH – Federal Office of Public Health
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMD - Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Responsibilities ↦ Site-Investigator

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): Development ↦ Management ↦ Responsibilities ↦ Site-Investigator

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