What is it? Why is it important?

The feasibility questionnaire asks a set of relevant questions that evaluates whether study implementation and conduct is possible and manageable.

Topics to be addressed are:

  • Feedback on the scientific interest of the study
  • Feasibility of study design (e.g. blinded, randomised, control group)
  • Study management issues (e.g. data handling, site coordination, infrastructure, IMP/MD availability)
  • Readiness of participant study site(s) (e.g. resources, infrastructure, know-how)
  • Estimation of potential participant recruitment
  • Anticipate regulatory requirements, timelines and budget

More

The feasibility questionnaire ensures that all aspects pertaining to the successful implementation and conduct of a study are addressed.

Some aspects might require that questions become rather detailed.

Example

If study participants are asked to complete questionnaires online:

  • Do participants have access to a personal e-mail address?
  • Are participants familiar with logins, downloading and forwarding of documents?
  • Are e-mail addresses compatible allowing accesses to study documents?
  • How are data protection issues handled?
  • How is trouble shooting managed?
  • How is the data merged with the main database?
  • How is data import validated?
  • Etc.

What do I need to do?

Based on the planned set-up of your study:

  • Define study relevant feasibility questions
  • Leave space for the Site-INV to include questions, comments and suggestions
  • Add a section that allows for experiences and lessons learned from previous studies

Writing a feasibility questionnaire can be quite challenging as not all eventualities are predictable. Some aspects might only become apparent during study conduct.

More

Taking time to assess feasibility is an important investment as it avoids problems that potentially could occur.

Problem management during study implementation and conduct will delay the study and most likely require additional resources and funding.

When writing the feasibility questionnaire:

  • Use easy language that is well understood by readers
  • Allow enough space for answers
  • Give a reasonable deadline for answering all questions
  • Collect and analyse all answers in order to decide on how to proceed
  • The Site-INV completes all feasibility questions
  • As applicable, add personal comments, suggestions and questions
  • Give feedback within the deadline given by the SP-INV

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 for Quality management
Abbreviations
  • CTU – Clinical Trials Unit
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Concept ↦ Quality and Risk ↦ Study Feasibility ↦ Feasibility Questionnaire
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 ↦ Study Feasibility ↦ Feasibility Questionnaire

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