What is it? Why is it important?

Depending on their roles and responsibilities study team members can give important feedback regarding the feasibility of a study.


Based on the complexity of the study, the study staff can provide important information on:

  • The study design: such as resources, definition of work flow and processes, required time investment and expertise, access to study participants
  • Infrastructure: such as special equipment, access to patient rooms, labs, access to storage space for biological material, study documents, and investigational product (e.g. IMP/IMD)
  • Experience: such as data entry and lessons learned from previous studies


Feedback should be collected from all parties involved, SP-INV team and Site-INV team. SP-INV makes final decision regarding study feasibility and whether to implement a study as planned.


Any QMS measures required for study set-up and implementation only start after the study is deemed feasible (e.g.planning and implementing study required SOPs / WIs / processes, extent of study monitoring / data management).

What do I need to do?

As a study team member and based on expertise:

  • Carefully read the protocol and if applicable the IB
  • Provide comments or address open issues with a problem solving approach
  • Provide suggestions with potential improvements to planned processes rand tasks (e.g. consider quality control and quality assurance aspects)
  • Assess and provide comments on the feasibility questionnaire(s), and inform the Site-INV or SP-INV of any potential risks or issues identified during the feasibility assessment


As a Site-INV forward the study staff feasibility assessment to the SP-INV within deadline

Where can I get help?

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


ICH GCP E6(R2) – see in particular guideline

  • 5.0 Quality management

ISO 31000 (access liable to costs) – see in particular section

  • Risk management: Principles and guidelines
  • CTU – Clinical Trials Unit
  • IB – Investigator Brochure
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO – International Organisation for Standardisation
  • QMS – Quality Management System
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Concept ↦ Quality and Risk ↦ Study Feasibility ↦ Study Team

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 ↦ Quality and Risk ↦ Study Feasibility ↦ Study Team

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