What is it? Why is it important?

A Sponsor-Investigator (SP-INV) carries the main responsibility for a study, including potential participating study sites in a multicentre study.


Responsibilities include the:


The SP-INV both:

  • Initiates and conducts, alone or with others, a clinical study
  • Retains ongoing study oversight from start to finish, including the archiving of study documents
  • Directs to whom the IMP/IMD is administered and dispensed (to Site-INV)


The term does not include any person other than an individual. It does not include a corporation or an agency.

What do I need to do?

As a SP-INV:

  • Familiarize yourself with SP-INV responsibilities
  • Retain ongoing oversight regarding study activities including its delegated tasks
  • Attend GCP training courses for the use of Investigational Medicinal Products (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 an applicable medical profession and have the professional knowledge and scientific expertise required 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 a study applicable non-medical profession


As a SP-INV you carry both:

  • Sponsor responsibilities: with the main and overall responsibility for a study, which in a multi-centre study includes the responsibilities over several participating study sites
  • Investigator responsibilities: represents the responsibility for a particular study site. A site responsible investigator is named the Site-INV


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


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


As a SP-INV, write-up, define, and implement among others the following study documents and processes:


These processes may need the input and support from various experts (e.g. data manager, statistician, project and safety manager, monitor, regulatory expert, study nurse)

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

  • 1.53 SP-INV definition
  • 5 SP-INV responsibilities
  • 8 Essential study documents

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

  • 3.49 Sponsor definition (SP-INV)
  • 9 Responsibilities of the sponsor (SP-INV)

Swiss Law

ClinO – see in particular article

  • Art. 6 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • HRO – Human Research Ordinance
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO – International Organization for Standardization
  • TMF – Trial Master File
  • QMS – Quality Management System
  • RA – Regulatory Authorities
  • TMF - Trial Master File
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • WHO – World Health Organization
Development ↦ Management ↦ Responsibilities ↦ Sponsor-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 ↦ Sponsor-Investigator

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