What is it? Why is it important?

In studies, the safety of study participants and the quality of study data must be guaranteed through:

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

 

QA activities are defined prior to study start, and can include:

 

QC activities are implemented during study conduct, and can inlcude:

 

The SP-INV defines the required QA and QC activities of a study. The Site-INV of a participating study site(s) is required to comply with its defined activities.

What do I need to do?

As a SP-INV, define the QA activities of your study, such as to:

  • Establish a risk-based QMS: Based on the study protocol, assess potential risks to data quality and participant safety and define:
  • Establish a risk-based monitoring strategy: Based on study complexity and potential risks to study participants. Define a study monitoring plan
  • Develop a QA based database: Validate data collection procedures and tools (e.g. calculated fields, 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). Develop a data management plan.
  • Ensure staff qualification and infrastructure: Define qualification and training requirements for your study staff. Only delegate responsibilities to qualified staff able to comply with QA specifications

 

Define QC activities evaluating QA compliance during study conduct

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 - 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

Documents

Risk Assessment Form for Clinical Research Projects

Abbreviations
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Quality ↦ Implementation

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