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:

  • Abbreviations:
    • AE = Adverse Event
    • AR = Adverse Reaction
    • ADR = Adverse Drug reaction
    • ADE = Adverse Device Effect
    • DD = Device Deficiency
    • IVD = In Vitro Device
    • MP = Medicinal Product
    • IMP = Investigational Medicinal Product
    • MD = Medical Device
    • IMD = Investigational Medical Device
    • SAE = Serious Adverse Event
    • SAR = Serious Adverse Reaction
    • SADR = c
    • SUSAR = Suspected Unsuspected Adverse Reaction
    • SADE = Serious Adverse Device Effect
    • SE = Serious Event
  • Terminologies:
    • Safety data
    • Safety vigilance
    • Safety documentation
    • Safety assessment
    • Safety reporting
    • Safety risk-benefit ratio
    • Reference Documents
    • Annual safety report
    • Clinical study report

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Basic ↦ Safety ↦ Safety Terminology ↦ Overview

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

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

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

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): Basic ↦ Safety ↦ Safety Terminology ↦ Overview

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