What is it? Why is it important?

The aim of quality control (QC) is to periodically review given procedures and processes implemented in a study in order to ensure that the study:

  • Is conducted in compliance with the study protocol, SOPs, GCP, and the law
  • Data is correctly generated, collected, handled, and analysed

QC is an integral part of QA and includes activities and techniques used to systematically check applicable study compliance. Non-compliance results in findings that must be addressed and resolved.

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The SP-INV is responsible for the implementation of a risk-based QMS. A risk-based approach to QMS includes methods used to define and control risks in order to ensure the safety and quality of the study.

Example of QC measures

Monitoring is an important medium used by the SP-INV to evaluate compliance and perform QC checks at participating study sites.

Quality indicators include, but are not limited to:

  • Patient eligibility criteria consistently respected and abided by as defined in the study protocol
  • IC process correctly documented ensuring traceability
  • Adherence to safety reporting timelines
  • Scheduled visits and applicable procedures are followed and documented (e.g. blood draw, questionnaire, timing)
  • Data entry completed within timelines
  • Study visit documented in CRF, updates entered in medical records
  • Documentation on staff trainings (e.g. GCP, IC process, IMP/MD handling)
  • Correct handling of IMP/MD (e.g. access and temperature control, inventory log with traceability on dispense, return, destruction)

What do I need to do?

Define the QC strategy for your study by defining control measures according to identified risks, such as:

  • eCRF automatic alerts in the event of out-of-range data entries
  • 24 hours temperature surveillance of freezers storing biological material
  • Adaptions regarding number of monitoring visits, extent of checks, type of visit, (e.g. on-site versus central)
  • Extend of data processing checks

Monitoring is an important QC activity used to monitor study conduct.

For more information refer to Monitoring in this Study Guide

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In order to ensure compliance to QC control measures its strategy should be documented.

For each study provide applicable:

  • Written SOPs and WIs. These documents give detail guidance on how standards, processes, and given requirements should be implemented in core study activities - in every day work
  • Guidance on the handling of risk control measures. Use the RAT to document the risk control measures of your study
  • Risks are classified based on risk tolerance, reduction or prevention
  • Define applicable risk control measures (e.g. consult respective experts)
  • Communicate implemented risk measures to study team including related quality document
  • Ensure to train staff on QC measures of your study

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

  • 1.47 QC definition
  • 5.1 Quality assurance and quality control
  • 5.18 Study monitoring

ISO 9001:2015 – see in particular section

  • Quality Management Systems (access liable to costs)

Documents

Abbreviations
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • GCP – Good Clinical Practice
  • IC – Informed Consent
  • IMP/MD – Investigational Medicinal Product / Medicinal Device
  • QA – Quality Assurance
  • QC – Quality Control
  • QMS – Quality Management System
  • RAT – Risk Assessment Tool
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instruction
Development ↦ Quality and Risk ↦ Quality Control ↦ 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 Control ↦ Aim

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