What is it? Why is it important?

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

 

Responsibilities include:

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The SP-INV:

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

A SP-INV must exercise an applicable medical profession and have the professional knowledge and scientific expertise required for the planned study. If a medical profession is not required (e.g. Other Clinical Studies, research projects under the HRO ordinance), exercise a relevant non-medical profession

This term SP-INV specifically refers to an individual and excludes entities such as corporations or agencies.

What do I need to do?

As a SP-INV:

  • Familiarize yourself with SP-INV responsibilities
  • Ensure to have the required professional trainings for study conduct, such as to have and/or guarantee the required:
    • Qualification, knowledge, and experience
    • Knowledge and skills in the areas of data security and data protection
    • Legal knowledge for governing studies
  • Retain ongoing oversight of study activities, including delegated tasks
  • Attend GCP training courses on the use of Investigational Medicinal Products (IMP) (e.g. ClinO studies)

 

As a SP-INV you carry both:

  • Sponsor responsibilities: overall responsibility for a study, which in a multi-centre study includes all 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.

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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 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

References

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 articles

  • Art. 2d Definition sponsor
  • Art. 6 Professional qualifications

ClinO-MD – see in particular articles

  • Art. 2d Definition of sponsor
  • Art. 5 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
Abbreviations
  • 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
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 Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Responsibilities ↦ Sponsor-Investigator

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