What is it? Why is it important?

In studies, the safety of study participants and the quality of study data must be guaranteed. To ensure that safety and quality are maintained throughout study conduct, requires the implementation of quality aspects:

  • Quality Assurance (QA)
  • Quality Control (QC)


QA activities are procedures defined prior to study start, such as:


QC activities are tasks executed during study conduct, such as:


The SP-INV of the study defines the required QA and QC activities, which must be complied with by the Site-INV at any participating study site(s).

What do I need to do?

As a SP-INV, define the Quality Assurance activities of your study, such as:

  • The establishment of a risk-based QMS: Based on the study protocol, assess potential risks to data quality and participant safety and define:
  • Planning of a risk-based monitoring: based on the complexity of the study and potential risks to study participants define a study monitoring plan
  • Study database development: define and validate data collection procedures and tools (e.g. questionnaires, lab reports). Throughout the data lifecycle (from collection until analysis), define risks where study data might become distorted due to people’s influence or other external factors (e.g. data import and export)
  • Study qualification and infrastructure: Define the qualification and training requirements of your study staff. Ensure study tasks and responsibilities are only delegated to qualified staff able to ensure ongoing compliance with QA specifications


Define QC activities that evaluate QA compliance during study conduct

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
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • QA – Quality Assurance
  • QC – Quality Control
  • QMS – Quality Management System
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedures
  • WI – Working Instructions
Development ↦ Management ↦ Study Quality ↦ Implementation

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 ↦ Management ↦ Study Quality ↦ Implementation

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