What is it? Why is it important?

The aim of Quality Control (QC) is to periodically review implemented procedures and processes in the study in order to ensure that:

  • The study is conducted in compliance with the study protocol, study SOPs, ICH GCP, and applicable laws (e.g. Swiss law)
  • Data is correctly generated, collected, handled, and analysed


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


In this regard, the SP-INV is responsible to implement a risk-based QMS. A risk-based approach to QMS aims at managing study risks needed 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:

What do I need to do?

As a SP-INV define the QC strategy for your study. Base QC control actiivities according to identified study risks, such as:

  • eCRF automatic alerts in the event of out-of-range data entries
  • 24 hours temperature surveillance of freezers storing biological material, including an efficacy check of the emergency plan process
  • Ongoing study monitoring adaptions (e.g. number of total visits, extent of document and SD checks, type of monitoring visit  (e.g. on-site, centralised)
  • Extend of data processing checks


Monitoring is an important QC activity used to monitor study conduct. In order to ensure compliance with QC activities its strategy should be documented in a monitoring plan.


For more information refer to Monitoring in this Study Guide


Based on the QC strategy of your study provide applicable:

  • Written SOPs and WIs: These documents give detailed guidance on how standards, processes, and given requirements should be implemented in study core activities - in daily work
  • Guidance on the handling of study risks, by documenting the risk management of your study in a RAF (e.g. including quality document)
  • Ensure to train staff on the QC activities of your study

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

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

ISO 9001:2015 (access liable to costs) – see in particular section

  • Quality Management Systems


  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • IC – Informed Consent
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • IMP/IMD – Investigational Medicinal Product / Investigational Medicinal Device
  • QA – Quality Assurance
  • QC – Quality Control
  • QMS – Quality Management System
  • RAF – Risk Assessment Form
  • SD – Source Data
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instruction
Development ↦ Quality and Risk ↦ Quality Control ↦ 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 Control ↦ Aim

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