What is it? Why is it important?

Site feasibility (SF) indicates whether a potential study site is suitable to participate in a planned study.

SF checks include, but are not limited to an analysis of:

  • Site-INV
    • Interest in study participation
    • Sufficient time to invest in a study
    • Not active in any competing studies
    • Experience in conducting similar types of studies
  • Resources

More

  • A SF check should address all aspects pertaining to the successful conduct of a study.
  • Taking time to assess feasibility is an important investment because it avoids problems that potentially could have been prevented.
  • Managing problems during study implementation and conduct will delay and most likely require additional resources and funding.

Example

Some aspects may require more detailed investigations. An example would be the handling and storing of biological samples:

  • Does the site have access to freezers at the required temperature (e.g. −80°C)?
  • How are freezer access rights managed?
  • How is freezer temperature monitored?
  • Are there emergency procedures installed in the event of freezer failure?
  • Are there adequate sample shipment procedures?

What do I need to do?

Depending on how you plan to set up your study, you need to:

  • Define study relevant feasibility questions
  • If applicable, add questions addressing issues from your past experiences or lessons learned from previous similar studies
  • Leave space for the Site-INV to include questions, comments, and suggestions

Writing a feasibility questionnaire can be quite challenging because not all eventualities can be predicted. Some aspects may only become apparent during study conduct.

More

Explicit questions could be included in a feasibility questionnaire, such as, does the site have:

  • Sufficient time and adequate resources?
  • A sufficient number of participants potentially willing to participate in the study?
  • Ability to adhere to required safety reporting procedures (e.g. 24-hour emergency cover)?
  • Appropriate storage facilities for IMP/MD?
  • Appropriate procedures for handling IMP (e.g. storage, processing, and shipment procedures)?
  • A suitable QMS in place (e.g. SOPs, WIs, staff trainings, relevant processes for managing study tasks)?
  • No competing studies to be conducted in parallel which would jeopardize the adequate amount of participants available for the study?

A site feasibility check can be done remotely or on-site. Nevertheless, a personal visit to the site is often advisable. Many study aspects are difficult to check remotely, such as required infrastructure and facilities.

It is always an advantage to establish a personal contact with an on-site study staff member. This makes it easier to evaluate the site, establish a robust communication line, and solve future problems.

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 guidelines

  • 4.5 Protocol compliance
  • 5.6 Investigator selection
  • 5.18 Monitoring activities

ISO 14155 Medical Device – see in particular section (access liable to costs)

  • 6.8 Investigation site selection
  • 9.2.4 Monitoring
  • 10.3 Qualification of investigation site
Abbreviations
  • CTU – Clinical Trials Unit
  • Site-INV – Site Investigator
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • IT – Information Technology
  • QMS – Quality Management System
  • SF – Site Feasibility
  • SOP – Standard Operating Procedure
  • WI – Working Instruction
Concept ↦ Monitoring ↦ Monitoring ↦ Site 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 ↦ Monitoring ↦ Monitoring ↦ Site Feasibility

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