What is it? Why is it important?

The sponsor-investigator (SP-INV) is responsible to define and the set-up a risk-based QMS in order to ensure participant protection and reliability of study results.


  • Defines roles & responsibilities
  • Identifies potential study risks from concept to completion
  • Assesses frequency of risk occurrence and impact (REM)
  • Anticipates and defines risk control measures
  • Includes risks 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?

  • Check competitors to decide whether the planned study is still relevant
  • Collect feedback and lessons learned from feasibility studies
  • Select applicable experts able to contribute and brainstorm regarding potential risks to the planned study (e.g. schedule ad hoc meetings)
  • Perform an initial risk evaluation including potential mitigating measures
  • Document any risk assessment including its management in the RAT


  • The complexity of your study will have a significant effect on potential inherent risks, including the QMS required to control these risks
  • Study aim, design and complexity should be adapted according to the information needed to answer your study question. Activities above these requirements will only negatively burden staff, timeline, and finally your budget (e.g. collection of information and data not needed to answer question(s)
  • Activities needed to identify and manage risks during study planning and conduct require additional resources. Remember to make applicable budgetary adaptations

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

  • 5.0 Quality management

ISO 31000 – see in particular section

  • Risk management: Principles and guidelines (access liable to costs)


  • Risk Assessment Tool (RAT) – Template: A tool to assess study risks
  • Risk Evaluation Matrix (REM) – a grid: helps to categorise and prioritise study risks
  • CTU – Clinical Trials Unit
  • QMS – Quality Management System
  • RAT – Risk Assessment Tool
  • REM – Risk Evaluation Matrix 
  • SP-INV – Sponsor-Investigator
Concept ↦ Quality and Risk ↦ QMS Stakeholders ↦ Sponsor-Investigator

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

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

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

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): Concept ↦ Quality and Risk ↦ QMS Stakeholders ↦ Sponsor-Investigator

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