What is it? Why is it important?

The Sponsor-Investigator (SP-INV) carries the main responsibility for a study, such as:

  • Selection of study design
  • Set-up of study database
  • Implementation of a risk based QMS (e.g. study monitoring, auditing, ongoing risk management)
  • Process required for safety monitoring, evaluation and reporting
  • Handling of IMP/MD (e.g. storage specifications)
  • Submission to EC and applicable regulatory authorities
  • Financial guarantee from concept until study completion
  • Applicable study insurance
  • Set-up of partner contracts
  • Clinical Study Report
  • Registration in a primary registry recognised by WHO or clinicaltrials.gov
  • Publication of all research related work

More

A SP-INV is an individual that carries both SP and INV obligations and responsibilities.

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/MD 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:

  • Be familiar with legal requirements for the SP-INV
  • Have GCP training for IMP studies (note: additional GCP courses are required for SP-INVs)
  • Have ISO 14155 training for MD studies
  • Exercise the applicable medical profession and have the required professional knowledge and scientific expertise
  • Exercise the applicable type of research according ClinO (e.g. investigational medicinal product versus medical device versus transplantation versus other clinical studies according to ClinO)
  • If no medical profession is needed and if applicable, exercise another profession (non-medical) for ClinO chapter 4 studies or studies performed under the HRO ordinance (e.g. research or further use of data involving measures for sampling of biological material or collection of health-related personal data)

Depending whether you are a SP-INV or Site-INV will highly affect types of obligations and responsibilities.

More

Write-up, define, and implement the following study documents and processes:

Defining these processes may need the input of different specialists.

Where can I get help?

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

External Links

Swissethics – in particular see

  • 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 article

  • Art. 6 Professional qualifications

HRO – see in particular article

  • Art. 4 Professional qualifications
Abbreviations
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA - Ethics Committee / Regulatory Authorities
  • ClinO – Clinical Trials Ordinance
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • HRO – Human Research Ordinance
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • TMF – Trial Master File
  • QMS – Quality Management System
  • RA – Regulatory Authorities
  • 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 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): Development ↦ Management ↦ Responsibilities ↦ Sponsor-Investigator

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