What is it? Why is it important?

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

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

 

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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
  • 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?

Throughout all study phases:

  • 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 preventative measures proportionate with potential study risks.

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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. GCP)
  • Study relevant SOPs are available, current and trained
  • Site infrastructures are able to accommodate study requirements (e.g. IMP/MD handling, work space, storage of biological samples)

Where can I get help?

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

References

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)

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • CV – Curriculum Vita
  • GCP – Good Clinical Practice
  • 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 ↦ Risk Based
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): Basic ↦ Quality and Risk ↦ Quality Management ↦ Risk Based

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