What is it? Why is it important?

When wanting to implement a given study idea, various factors must be considered so as to evaluate whether the idea can be implemented in a research setting.

Aspects to consider include:

  • Access and availability of study participants at study site?
  • Qualified staff?
  • Required infrastructure (e.g. offices, patient rooms, storage facilities, laboratories)?
  • Access to alternative study sites (e.g. multicentre studies)?
  • Adequate financial means to cover the study?
  • Ample time at disposal for realising the study?

What do I need to do?

Based on the planned study, define requirements. Decide what factors are present and which ones are missing.

As applicable, clarify access to:

  • Site internal/external qualified staff and partners
  • Study participants at your site
  • Required infrastructure and resources
  • Additional study sites and their inclination to participate
  • Available funds

Important is also to assess the feasibility of your study design (e.g. how would randomisation procedures be implemented, drugs administered).

For more information refer to Feasibility in this Study Guide.

More

When recruiting hospital internal/external partners such as alternative study sites, hired service providers, and study staff, you should:

  • Perform a feasibility check of any potential collaborating site in order to assess suitability
  • Evaluate adequacy of staff qualification and expertise needed to fulfil study tasks and responsibilities (e.g. project manager, study nurse, study coordinator)
  • Ensure qualification of hired partners in order to guarantee for the quality of provided services (e.g. certified laboratories, use of a GCP-compliant database, qualified study monitor)

Successful study implementation will depend on the expertise and professionalism of study staff and partners participating or supporting your study.

Where can I get help?

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

External Links
SAMS – see in particular

  • Research with human subjects

References

ICH GCP E6(R2) – see in particular guidelines

  • 4.2 Adequate resources
  • 5.3 Medical expertise
  • 5.1 Trial design
  • 5.5 Trial management
  • 5.6 Investigator selection
  • 5.7 Allocation of responsibilities
  • ICH Topic E8 – see in particular guidelines
  • 2.2 Scientific approach in design and analysis

ISO 14155:2020 Medical devices - see in particular sections (access liable to costs)

  • 6.3 Justification for the design of the clinical investigation
  • 9 Responsibilities of the sponsor (SP-INV)
Abbreviations
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • SP-INV – Sponsor-Investigator
  • SAMS – Swiss Academy of Medical Sciences¬
Concept ↦ Management ↦ Study Idea ↦ Implementation
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 ↦ Management ↦ Study Idea ↦ Implementation

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