What is it? Why is it important?

When planning the implementation of a given study idea, various factors must be considered in order to evaluate whether the idea can be implemented in a research setting.

Study feasibility is a process with the aim to evaluate the possibility of conducting a study (e.g. at a particular study site).

The SP-INV must be able to guarantee adequate financial resources needed to cover all study costs from start until completion. A financial guarantee must be provided prior to study start and during the concept phase of the study.

The objective is to guarantee the successful implementation and completion of a study, with respect to study safety, data quality, planned timelines, and budget. In this respect, the feasibility questionnaire becomes an important tool in ensuring successful project planning.

More

In the event of a multi-centre study, the SP-INV is responsible to perform feasibility checks at each participating study site. In addition, the feasibility of added costs and resources due to their participation in the study must be evaluated.

Feasibility checks can be outsourced to a CRO or CTU, but main responsibility and decision whether a site is suitable to participate in a study remains with the SP-INV.

What do I need to do?

Based on the complexity of your study design outline feasibility checks that evaluate:

  • Access to an adequate number of study participants needed to answer the study question(s) within an acceptable timeframe
  • The ability to perform planned medical examinations (e.g. access to analytical device(s), provision of infrastructure, staff expertise)
  • The qualification of site staff
  • Provision of additional time needed for study management
  • Infrastructure requirements (e.g. offices, patient rooms, storage facilities, labs)
  • Access to potential partners needed for study conduct (e.g. internal and external)
  • Access to additional study sites qualified for study participation
  • Access to funds and resources needed to complete the study

Based on study requirements:

  • Draft a realistic financial study budget
  • Seek and obtain guarantees from partners able to financially support and cover study costs

Where can I get help?

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

Abbreviations
  • CRO – Clinical Research Organisation
  • CTU – Clinical Trials Unit
  • SP-INV – Sponsor Investigator
Concept ↦ Documents ↦ Required Documents ↦ Feasibility
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 ↦ Documents ↦ Required Documents ↦ Feasibility

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