What is it? Why is it important?

The aim of quality assurance (QA) is to provide confidence that applicable regulations and systematic activities are met in order to safeguard patients and data quality.

QA measures are defined in the QMS and are put in place to:

  • Prevent mistakes, problems, or defects with established processes, products or services
  • Guarantee data quality and provide confidence that given study results are reliable and credible
  • Ensure protection of study participants
  • Ensure compliance with applicable regulations, guidelines, standards and required procedures

More

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, but assure that data is generated, documented and reported in compliance with GCP and applicable regulatory requirement(s)

What do I need to do?

  • Implement and maintain a QA system for study set-up and conduct
  • Describe specific processes with written SOPs, WIs (e.g. for safety reporting, randomisation procedures, IC procedures)
  • Describe procedures needed to record and report study data based on GCP, regulatory requirements, and specifications given in the study protocol
  • Ensure that study staff is appropriately trained on their individual tasks and responsibilities

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

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 quality control

ISO 9001:2015 – see in particular section

  • Quality Management Systems (access liable to costs)
Abbreviations
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • GCP – Good Clinical Practice
  • IC – Informed Consent
  • 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
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): Development ↦ Quality and Risk ↦ Quality Assurance ↦ Aim

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