What is it? Why is it important?

The aim of Quality Assurance (QA) is to provide confidence that applicable procedures and systematic activities are met, so as to guarantee the safety of study participants and quality of study data.


QA measures are defined processes, products, or services documented in the Quality Management System (QMS) of the study. They are risk-based and put in place to:

  • Prevent mistakes, problems, or defects
  • Guarantee data quality with the aim to provide confidence in study results (e.g. study results are traceable and credible)
  • Ensure the rights and ongoing safety of study participants during study conduct, and as applicable follow-up
  • Ensure the ongoing compliance with applicable laws (e.g. Swiss law), Ethics Committee (EC), regulatory authorities (RA) (e.g. Swissmedic, FOPH), guidelines (e.g. ICH GCP, ISO 14155), and local procedures (e.g. SOPs, WIs)


The aim of QA in a study is to give assurance to the SP-INV and ultimately to EC/RA that processes are reliable and that no major system failures are expected to occur that would:

  • Expose patients to unnecessary risks or violate their legal or ethical rights
  • Risk the integrity of study results (e.g. data must be generated, documented and reported in compliance with ICH GCP and applicable regulatory requirements)

What do I need to do?

As a SP-INV:

  • Implement and maintain a QA system covering study set-up and conduct, and if applicable follow-up
  • Describe and document QA relevant processes in SOPs and WIs (e.g. the informed consent process, safety reporting procedures, randomisation procedures)
  • Describe QA procedures for data entry and data handling during study conduct
  • Describe QA procedures to ensure compliance with the study protocol, EC, ICH GCP and regulatory requirements
  • Ensure study staff is properly trained on QA procedures and their respective tasks and responsibilities

SOPs and WIs give details on how QA guidelines, standards and requirements will be implemented in core study activities - in daily work.

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
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FOPH – Federal Office of Public Health
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • QA – Quality Assurance
  • QMS – Quality Management System
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Development ↦ Quality and Risk ↦ Quality Assurance ↦ Aim

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): Development ↦ Quality and Risk ↦ Quality Assurance ↦ Aim

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