Sponsor Protocol Feasibility Questionnaire – Drug Study
Please complete the following questionnaire designed to provide OCRSS with protocol
feasibility information and return by e-mail to ocrss@louisville.edu or by fax to (502) 8522610 within 3 business days. This information is essential for our determination of
resource availability at the University of Louisville to fulfill the requirements of the
protocol. We will be able to finalize our feasibility analysis of the protocol with the receipt
of your responses.
Study Title
NCT number from clinical
trials.gov if applicable
OCRSS Representative(s)
ocrss@louisville.edu
Principal Investigator (if
known) or interested
investigators
Name:
Address:
Sponsor name and contact
details
Phone:
Fax:
E-mail:
Name:
Address:
CRO name, if applicable,
and contact details
Phone:
Fax:
E-mail:
Name:
Address:
Sponsor/CRO contact details
for contract related invoicing
Phone:
Fax:
E-mail:
OCRSS Sponsor Questionnaire
Version: 6/27/2011
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If a CRO is involved, who will
be the contracting party for
the Clinical Study
Agreement?
Sponsor
CRO - If the CRO will be the contracting party, please provide
a template Letter of Indemnification from both the CRO and the
Sponsor along with the other template contracts.
Do you have a Facility Use Agreement template that you use
when research will be conducted at an outside location?
no
Many of the clinical sites are
"outside" locations (a
location not owned or
controlled by the Institution
and not a party to the Clinical
Study Agreement).
yes, please provide
OR
Do you have a Letter of Indemnification template that you use
when an outside location is not a party to the Clinical Study
Agreement and a Facility Use Agreement is not used?
no
yes, please provide
Expected date for site
selection to be completed?
How many sites are
planned?
How many sites have been
selected?
How many sites have
submitted to IRB?
How many sites have been
initiated?
Provide the date for planned
(or actual) first subject in
(signed consent).
Provide the date for planned
last subject in.
no
yes on (date) _______________________________
Is an Investigator meeting
being planned?
in (city, state)____________________________
expected attendees
Investigator
SC
other, specify____________________
Are there any specialist
investigators required other
than the PI such as
pharmacist, surgeon,
cardiologist, etc?
OCRSS Sponsor Questionnaire
Version: 6/27/2011
no
yes, describe________________________________
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Provide the planned total
randomized subjects in
entire protocol.
How many subjects are
currently randomized (if
study is already started)?
What are the enrollment
expectations at our site?
#___________ randomized as of (date)______________
#___________ randomized as of (date)______________
What are the expected /
actual screen failure rates?
What are main reasons for
screen failure (expected or
actual)?
What are enrollment rates at
initiated sites?
Average #__________ randomized per month
Is there someone at an
initiated site we can call to
discuss the study?
Are there expected/actual
challenges with the protocol?
Provide a list of any
disallowed medications for
inclusion in the study.
Is there a final protocol
available?
no, expected to be issued______________________
yes, please send to ocrss@louisville.edu
no
Will a consent template be
provided for IRB
submission?
Will there be periodic
teleconferences or web
meetings?
yes
If applicable, will assent templates be provided for separate age
groups (i.e. teenage vs. 4-10)?
no
yes
no
yes
frequency (weekly, monthly):
expected attendees (inv, SC):
email or CD – required by UofL IRB
hard copy – we need at least 2 copies of each
How are study documents
provided?
web-based, secure document-sharing repository
intralinks
company’s own system
OCRSS Sponsor Questionnaire
Version: 6/27/2011
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Will a source document
template be provided?
no
yes
no
yes, Do you require transcription
Is there a patient diary?
by study staff?
no
yes, Is the transcription
paper
EDC
paper
Please specify the CRF type.
EDC:
web-based, vendor_____________________
sponsor computer required
sponsor’s own web-based system
How many CRF pages or
tabs / subject?
fax
What is the method of CRF
submission?
UPS / FedEx / DHL
monitor sends in
downloaded EDC
What is the frequency of
monitoring visits after first
visit?
web-based EDC
Minimum of every ___________ weeks
Are there any special
storage requirements for the
investigational product or
clinical trial materials?
no
Are there central or required
local labs?
Local, _________________________
Will lab and shipping
supplies be provided?
no
Will dry ice be required?
no
Do you anticipate collecting
and keeping any additional
samples from subjects for a
bio-repository?
yes, please explain.
_________________________
_________________________
Central – Please provide Lab Manual
yes
yes, for which visits_____________________
no
yes
If yes, is this a sub-study or a required element of the main
protocol? _______________________________________
Is there any reason we
cannot post the study on our
web page for recruitment?
no
yes
Is there a budget for local
advertising?
no
yes
OCRSS Sponsor Questionnaire
Version: 6/27/2011
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Do you require one page
CVs in a sponsor form for all
study team?
no
Provide the record retention
requirements for this
protocol.
__________ years after study completion
yes
until notified by sponsor
Any other special study
requirements or equipment
needed?
What are study-training
requirements for Investigator
(e.g., sponsor required
remote training, attendance
at investigators meeting,
etc)?
Training method (CD, online)
Estimated time to complete
What are study-training
requirements for Study
Coordinator (e.g., sponsor
required remote training,
attendance at investigator
meeting, etc)?
Training method (CD, online)
Estimated time to complete
What are study-training
requirements for Regulatory
Coordinator (e.g., sponsor
required training for
document submittal, etc.)?
Training method (CD, online)
Estimated time to complete
Are all sponsor activities
related to this protocol
certified compliant with the
regulation 21 CFR Part 11?
Sponsor Protocol Feasibility
Questionnaire Completed by:
Date:
OCRSS Sponsor Questionnaire
Version: 6/27/2011
Phone number:
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