What is it? Why is it important?

A risk-based quality management system (QMS) addresses the aspect of identifying potential study risks as opposed to implementing a “one size fits all QMS”. Based on identified risks, the QMS of the study is adapted accordingly (e.g. required activities, processes, implemented risk control measures).


A risk-based QMS might include a risk-based:


A QMS represents a set of activities, processes, implemented measures in order to ensure:

  • Feasibility of study protocol and its design
  • Protection of study participants (e.g. safety, privacy, rights)
  • Study is conducted according to protocol and regulatory requirements (e.g. laws, ICH GCP, Declaration of HelsinkiISO 14155)
  • Quality and reliability of study results
  • Information is available for decision making (e.g. safety, study stop, competition with other researchers)


What do I need to do?

As a SP-INV or Site-INV:

  • Implement a risk-based QMS at study start
  • Maintain a risk-based QMS throughout all study phases, including study archiving
  • Ensure that in multi-centre studies Site-INV(s) comply with the risk-based QMS of the study


Use a risk-based approach with preventive measures proportionate with potential study risks.


Get an overview of the current QMS status at your site, and check whether:

  • Staff qualifications, CVs and certificates are up-to-date (e.g. ICH-GCP)
  • Study relevant SOPs are available, current and trained
  • Site infrastructures are able to accommodate study requirements (e.g. IMP/IMD handling, work space, storage of biological samples)

Where can I get help?

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


ICH GCP E6(R2) – see in particular guidelines

  • 5.0 Quality management
  • 5.1 Quality assurance and control assurance

ISO 9001:2015 – see in particular section

  • Quality Management Systems – (access liable to costs)



  • CTU – Clinical Trials Unit
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • CV – Curriculum Vita
  • GCP – Good Clinical Practice
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • TMF/ISF – Trial Master File / Investigator Site File
  • WI – Working Instructions
Basic ↦ Quality and Risk ↦ Quality Management System (QMS) ↦ Risk Based

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 Quality and Risk
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): Basic ↦ Quality and Risk ↦ Quality Management System (QMS) ↦ Risk Based

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