What is it? Why is it important?

In studies, when describing or communicating safety matters, many abbreviations and terminologies are used.

An overview of main:


Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

ICH GCP E6(R2) – see in particular

  1. Glossary

ICH - E2A – see in particular

  • II Safety definitions and terminology

ISO 14155:2020 Medical Devices (access liable to costs) – see in particular section

  • 3  Terms and definitions
Basic ↦ Safety ↦ Safety Terminology ↦ Overview

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): Basic ↦ Safety ↦ Safety Terminology ↦ Overview

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