An indepth look at feasibility questionnaires

1. An Indepth Look at
Feasibility Questionnaires
May 2018 Webinar

2. The Process of Acquiring New Studies
When a site is in the process of acquiring new studies,
sponsors will send to prospective sites:
1. A CDA: A confidentiality agreement that the site will have to fill out in order to
assure sponsors that any study specific information granted to the site will not
be disclosed with anyone outside of the site
2. A Protocol Synopsis: A document detailing what the study entails
3. A Feasibility Questionnaire: Also called “feasibility survey” or “site survey”

3. What is a feasibility questionnaire?
A questionnaire sent to the site by a sponsor in order to determine whether a site is
qualified to conduct the study as well as to project the site’s enrollment. The
answers to this survey will determine if the site will be considered for the study and
project how many patients the sponsor can expect to be enrolled at the site should
they be granted the study.

4. Key Facts
● Feasibility questionnaires are typically about 7-10 pages
● They may also be presented as online links/surveys
● CRAs will review and determine during the SSV and SIV whether what the site
states in the feasibility questionnaire is as accurate as possible
● For this reason, it is important to keep a copy of the answers on the feasibility
survey because you will be asked to confirm them later on

5. Most important questions on the feasibility survey
● How many patients can your site screen and enroll per month?
● How many patients are your PI or Sub-Is seeing per month that could meet the
eligibility criteria of the protocol?
● How many patients can your site screen and enroll throughout the course of
the study (within the enrollment window)?

6. Sponsors use these numbers to determine:
● Whether they need to bring on more sites and CRAs
● Where to position their sites and CRAs for adequate coverage
● The performance of the site when the projected numbers are compared with
the actual numbers at the end of the study

7. How do you determine what the projected numbers
should be on the feasibility questionnaire?
● Remember: the sponsor will hold you accountable for your projections
● The key is to play the balancing game between realistic numbers and the
numbers the sponsor expects to hear from you
● It is better to be conservative and then exceed their expectations rather than
give the sponsor huge expectations and then fall short

8. For example...
Site A:
Projected enrollment:
20 patients
Actual enrollment:
5 patients
Site B:
Projected enrollment:
5 patients
Actual enrollment:
5 patients
VS
Even though both sites enrolled the same amount of patients, site B will look better in
the eyes of the sponsor because they gave the most realistic enrollment projection.
Because of Site A’s unrealistic expectations, the sponsor will now have to find the
remaining 15 patients that the site had promised from somewhere else

9. Other information required on the feasibility survey:
● Institution/Site name and address
● Investigator information and experience
● Staff information and experience
● CRC information and experience
● Pharmacist information (if any)
● Site’s past experience with sponsor/CRO
● How many studies are currently running at the site
● How many studies are assigned per coordinator
The purpose of these questions is to give the sponsor a better understanding of
how a site is run/setup, the experience of the site, and the workload of the site staff
● Source of patient recruitment
(best answer is PI’s private practice or referrals)
● Advertising
● Site experience with therapeutic area
● Facility and equipment information
● EDC experience
● Local/Central IRB experience
● CLIA Certificate/Waiver
● Site staff accessibility

10. Remember!
Keep a copy of the answers on the feasibility
survey because CRAs will review and determine
during the SSV and SIV whether what the site
states in the feasibility questionnaire is as accurate
as possible!