What is it? Why is it important?

The aim of clinical research is to:

  • Improve our knowledge regarding human diseases
  • Improve our knowledge on how the human body works
  • Develop new or improved drugs
  • Develop new or improved medical devices
  • Develop new or improved diagnostic methods


In other words, to develop knowledge that improves human health or increases understanding of human biology.

As member of the scientific community, a researcher raises scientific questions and conducts studies to answer these questions.

What do I need to do?

As a SP-INV:

  • Be up-to-date with scientific literature in your field of interest
  • Ensure to invest in the planning of your study (e.g. access to required funding, collaborations with competent partners)
  • Ensure to comply with legal and regulatory requirements (e.g. the law, ICH-GCP, Declaration of Helsinki)
  • Acquire the required certificates and trainings needed to conduct studies (e.g. ICH-GCP certificate)


Before sharing any information, establish a Confidentiality Disclosure Agreement (CDA) between involved parties (even in academics).

Where can I get help?

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


  • CDA – Confidentiality Disclosure Agreement
  • CTU – Clinical Trials Unit
  • ICH GCP - International Council for Harmonisation Good Clinical Practice
  • SP-INV – Sponsor Investigator
Concept ↦ Ethics and Laws ↦ Research Aim ↦ Advancing Science

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): Concept ↦ Ethics and Laws ↦ Research Aim ↦ Advancing Science

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