What is it? Why is it important?

In order to guarantee the correct preparation, conduct and completion of a study, requires that key study players know and follow the Good Clinical Practice (GCP) guidelines.

GCP knowledge is confirmed through the attendance of a swissethics approved GCP course. A GCP course:

  • Is mandatory for SP-INVs and Site-INVs
  • The GCP certificate is included in the EC and Swissmedic submission dossier

The validity of a GCP course has no limitation, unless swissethics revises learning objectives due to GCP revisions.

Swissethics strongly recommends to maintain GCP knowledge on an ongoing basis by:

  • Performing research activities in different settings (e.g. increase knowhow on how to conduct studies)
  • Attending GCP refresher courses, including other research related training courses
  • Having the study site subjected to a GCP inspection (e.g. Swissmedic)

What do I need to do?

As a SP-INV and Site-INV:

  • Be familiar with swissethics recognised GCP courses
  • Attend a GCP course and obtain a recognised GCP certificate
  • Ensure study staff has adequate GCP knowledge
  • Ensure GCP principles are complied with during study planning and conduct

Where can I get help?

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

External Links

Swissethics – see in particular

  • Training / GCP courses
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GCP – Good Clinical Practices
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Development ↦ Ethics and Laws ↦ Liability ↦ Good Clinical Practice
Study
Basic

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

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
Set-Up

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
Conduct

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
Completion

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): Development ↦ Ethics and Laws ↦ Liability ↦ Good Clinical Practice

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