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.

  • Study design: such as resources, definition of work flow and processes, time investment, know-how, availability of study participants
  • Infrastructure: such as equipment, labs, access, storage space both for samples and Documents, patient room availability
  • Experience: such as lessons learned from previous studies

Feedback should be collected from all parties involved, SP-INV team and Site-INV team.

More

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. 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 delegated tasks:

  • 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 processes related to their tasks
  • 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 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

References

ICH GCP E6(R2) – see in particular guideline

  • 5.0 Quality management

ISO 31000 – see in particular section

  • Risk management: Principles and guidelines (access liable to costs)
Abbreviations
  • CTU – Clinical Trials Unit
  • IB – Investigator Brochure
  • QM – Quality Management
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • WI – Working Instructions
Concept ↦ Quality and Risk ↦ QMS Stakeholders ↦ Study Team
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): Concept ↦ Quality and Risk ↦ QMS Stakeholders ↦ Study Team

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