What is it? Why is it important?

The Sponsor-Investigator (SP-INV) is legally responsible to ensure the safety of study participants, the quality of study data, and the traceability of study results.

In order to safeguard these aims, a risk-based Quality Management System (QMS), including Quality Assurance (QA) and Quality Control (QC) procedures must be in place.


A risk-based approach includes to:

Risks should be included in an overall evaluation of the study in order to decide whether the study can be implemented as planned.

What do I need to do?

As a SP-INV:

  • Define how to set-up a risk-based QMS for your study. Focus on the safety of study participants and the quality of study data (e.g. include QA and QC procedures)
  • If applicable, consider regional or local QMS requirements (e.g. multi-centre studies)
  • Select applicable experts able to contribute to the identification of potential study risks (e.g. study staff, statistician, quality manager)
  • Define potential study risks including potential control-measures
  • Document the risk management of your study in a Risk Assessment Form (RAF)

Study aim, design should be tailored based on the information needed to answer your study question. The complexity of your study (e.g. design, target group) will have a significant effect on potential inherent risks, and the required QMS needed to control these risks. Activities above requirements will only negatively burden staff, timeline, budget, and increase the occurrence of risks


As a SP-INV you can delegate QMS responsibilities to:

  • A CRO or CTU, with a contract defining delegated tasks and responsibilities 
  • Study staff, with delegated tasks and responsibilities documented on a delegation-log

Still, ultimate responsibilities remain with the SP-INV, who ensures the qualification and training of the study staff including the competency of any potential partners.

Where can I get help?

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


ICH GCP E6(R2) – see in particular guideline

  • 1.54 Sponsor-Investigator
  • 4. Investigator
  • 5. Sponsor
  • 5.0 Quality management

ISO 31000 – (access liable to costs) see in particular section

  • Risk management: Principles and guidelines

Swiss Law

ClinO – see in particular article

  • Art. 2 Definitions



  • ClinO – Clinical Trials Ordinance
  • CRO – Contract Research Organisation
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • QA – Quality Assurance
  • QC – Quality Control
  • QMS – Quality Management System
  • RAF – Risk Assessment Form
  • SP-INV – Sponsor-Investigator
Basic ↦ Quality and Risk ↦ Risk-Based QMS 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): Basic ↦ Quality and Risk ↦ Risk-Based QMS Responsibilities ↦ Sponsor-Investigator

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