What is it? Why is it important?

The Implementation of a Quality Management System (QMS) represents a set of activities and processes, including protective and quality measures in order to ensure:

  • Feasibility of study protocol and its design
  • Protection of study participants (e.g. safety, privacy, rights)
  • Reliability of study results including tools and procedures for data collection and processing
  • Documentation of information essential for decision making (e.g. safety, study stop)

The implemented QMS of the study should be risk-based.


Undertaking a risk assessment of the study will gain knowledge and a deeper understanding of potential risks, and how these can be best mitigated.

  • Is a risk within acceptable levels or must it be reduced or even eliminated?
  • What would be preventive or alternative solutions?



What do I need to do?

Get an overview of the current QMS status at your site(s) and check whether:

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

Implement and maintain a risk based QMS throughout all study phases, and ensure Site-INV(s) comply with the study QMS.

Ensure risk control measures are proportionate to potential study risks.

For more information refer to Quality and Risk in this Study Guide.


Questions to ask can be:

  • What are potential study risks?
  • How high is the probability of risk occurrence?
  • What is the probability that a risk can be detected?
  • How should potential risks be prioritised?
  • What are the consequences if something goes wrong?
  • What would be applicable mitigating strategies/factors?

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 - Quality Management Systems (access liable to costs) – Requirements

ISO 14155:2020 Medical devices (access liable to costs) - see in particular section

  • 9.1 Clinical quality management


Risk Assessment Form for Clinical Research Projects

  • CTU – Clinical Trials Unit
  • CV – Curriculum Vitae
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • ISO – International Organization for Standardization
  • QMS – Quality Management System
  • SCTO – Swiss Clinical Trial Organisation
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedures
Development ↦ Management ↦ Quality Mgmt. System ↦ Implementation

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

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

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Quality Mgmt. System ↦ Implementation

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