Study and Site Feasibility Checklist

Once you have identified a commercial study, you will need to submit a feasibility questionnaire. These questionnaires are also known as expression of interest (EOI) forms or site identification forms and their purpose is to supply the information needed to a sponsor for a specific study. Information commonly requested includes contact details for the study team, available facilities, patient population, target timelines and previous experience. If you need support or advice on how to submit an EOI, contact us on ​supportmystudyeastmidlands@nihr.ac.uk.

Here are some questions to ask yourself to help assess feasibility at your site: 

• Will patients benefit from this research at your site?

• Are the recruitment and setup timelines realistic for the site?

• Does this study have potential to generate further research for the site?

• Does the study fit in with your commercial research goals?

Read the statement of activities (SoA), also known as the statement of events (SoE) and consider the following factors when assessing feasibility: 

• Is the site able to carry out all activities mentioned in the SoA or will additional support or training be needed?

• Is there appropriate space booked and facilities to carry out activities.

Look at the inclusion and exclusion criteria to help identify potential participants and consider the following: 

• Is there an appropriate database that can be used to identify potential participants?

• Explore recruitment methods for the study:

  • • Patient Identification Centres (PICs)

    • Opportunistic recruitment

    • Patient databases

    • Press releases and other media advertisements

Next, explore the logistical aspects of the study and how this could fit in with your site. Consider the following aspects:

• Find a suitable Principal Investigator (PI). Alternatively, enquire about the Associate PI Scheme (API) for mentoring and guidance for new PIs.

• Identify clinic spaces to use. 

• Estimate how long a clinic would take to complete the visits according to the SoA. 

• Staffing:

  • • Experienced staff or training available to staff

    • Identify a study coordinator

    • Identify a PI/Sub-I and pharmacists (if appropriate)

By asking all these questions, you can then identify what strengths your site has to offer, develop a suitable start-up timeline and target and submit this in the EOI.