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:

  • Set up and implement a risk-based QMS before 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 risk control measures proportionate to the significance of 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, archiving premises)

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 quality control

ISO 9001:2015 (access liable to costs) – see in particular section

  • Quality Management Systems



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

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 ↦ Quality Management System (QMS) ↦ Risk Based

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