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Explaining the Importance of Feasibility

Questionnaires and Site Selection Visits

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No matter if you’re reading this because you

aspire to become a CRA, or you’re a study

coordinator, or maybe you’re part of a

research site, learning about feasibility

surveys and questionnaires is important for

everyone that’s in any way involved in clinical

trials.

In this article, we’ll try to explain to you why

feasibility questionnaires and site selection

visits are important and how they can affect

the sponsor’s decision of awarding you the

study.

Explaining the Importance of Feasibility Questionnaires and Site Selection Visits

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Explaining the Feasibility Questionnaire

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When clinical research sites look for potential studies, they

usually email or fax the study manager or sponsor with their

pitch (presentation of the site and their interest in the study).

If they’re interested in your site as a potential partner, they

will usually first send you a CDA (confidential disclosure

agreement) which you have to sign.

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After you’ve done this, they will normally send you a

protocol synopsis as well as a feasibility questionnaire. This

document usually varies in form and length, although most

of them would be approximately 8 to 10 pages long.

Explaining the Feasibility Questionnaire

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Most Common Questions in a Feasibility Questionnaire

● How many patients can your site

enroll for the study?

● How many patients can your PI see on

a monthly basis?

● How many subjects can your site

screen on a monthly basis?

● How many subjects can you

randomize per month?

● Information about the site

investigators

● Staff information

● How many years of experience has

your main coordinator?

● Number of clinical trial coordinators

employed at the site

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How many clinical trials are given

to one coordinator? (in order to

check if your site coordinators

are overworked)

Do you have staff available

during holidays?

What sources would you use to

recruit your study participants?

(the best answers would be

from your own PI’s private

practice or physician referrals)

How many clinical trials have

you conducted in the past in

the same therapeutic area? (in

order to assess the site’s

expertise)

Most Common Questions in a Feasibility Questionnaire

Do you have staff that the

patients can reach 24/7 by

phone?

Have you worked with this sponsor

or CRO in the past?

Therapeutic specialty areas of the site PI (to see if the PI

fits the study that you’re applying for)

What types of

advertisements do you use

and how well do they

work?

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Most Common Questions in a Feasibility Questionnaire

Electronic medical records or paper-based records?

Have you used EDC platforms and which ones?

Do you have a CLIA certificate?

How many clinical trials do you have that are currently ongoing? (in order to find out if your staff, PI, and coordinator are overworked and how much attention will you be able to dedicate to their study)

The number of clinical trials your site has conducted in the last 5 years

Do you have any ongoing competing studies?

Do you have a secure subject record storage?

Do you own a double-locked drug room that’s temperature- controlled?

Has your site been inspected by the FDA, or have you ever received a warning letter from the FDA?

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The answers that you as a site, in this case, give to these

questions should be as close and as realistic as possible. At

the end of the trial, sponsors will look at your

performance, and they will see if you were able to reach

the numbers that you gave as an answer in the feasibility

questionnaire.

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The best thing you can do when answering these questions is to

be conservative! It’s much better if you gave a number of 5

enrolled patients and in the end you enroll 10 - which means you

exceeded their expectations - than to plan to enroll 20 patients

but then manage to enroll only 10. Being conservative and then

exceeding the expectations will make you - as a site - look better

and more professional in the eyes of the sponsors.

The worst thing you can do is over exaggerate

with the answers!

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The Importance of Site Selection Visits

The feasibility questionnaire that you give to sponsors will also be double-checked when they come for the site selection visit. Usually, a CRA will come to see your site and double-check the answers that you previously gave in the questionnaire.

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After the CRA checks if all the answers fit and are correct, the sponsor will either select your site and give you the study or he won’t. To ensure that there aren’t any problems during the site selection visit and that you increase your chances of being selected, always give the most appropriate and balanced answers in the feasibility questionnaire.

The Importance of Site Selection Visits

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Once you have reached the point of having a site selection visit, usually the chances are pretty big that the sponsor already wants to give you the study. However, if you make some big mistakes during this visit you might change his/her mind.

The Importance of Site Selection Visits