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 or by fax to (502) 852-2610 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) /
Principal Investigator (if known) or interested investigators
Sponsor name and contact details / Name:
Address:
Phone:
Fax:
E-mail:
CRO name, if applicable, and contact details / Name:
Address:
Phone:
Fax:
E-mail:
Sponsor/CRO contact details for contract related invoicing / Name:
Address:
Phone:
Fax:
E-mail:
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.
Many of the clinical sites are "outside" locations (a location not owned or controlled by the Institution and not a party to the Clinical StudyAgreement). / Do you have a Facility Use Agreement template that you use when research will be conducted at an outsidelocation?
no
yes, please provide
OR
Do you have a Letter of Indemnification template that you use when an outside location is not a party tothe Clinical Study Agreement anda 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.
Is an Investigator meeting being planned? / no
yes on (date) ______
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? / no
yes, describe______
Provide the planned total randomized subjects in entire protocol.
How many subjects are currently randomized (if study is already started)? / #______randomized as of (date)______
What are the enrollment expectations at our site? / #______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
Will a consent template be provided for IRB submission? / no yes
If applicable, will assent templates be provided for separate age groups (i.e. teenage vs. 4-10)? no yes
Will there be periodic teleconferences or web meetings? / no
yes frequency (weekly, monthly):
expected attendees (inv, SC):
How are study documents provided? / email or CD – required by UofL IRB
hard copy – we need at least 2 copies of each
web-based, secure document-sharing repository
intralinks
company’s own system
Will a source document template be provided? / no
yes
Is there a patient diary? / no
yes, Do you require transcription
by study staff? no
yes, Is the transcription paper
EDC
Please specify the CRF type. / paper
EDC: web-based, vendor______
sponsor computer required
sponsor’s own web-based system
How many CRF pages or tabs / subject?
What is the method of CRF submission? / fax UPS / FedEx / DHL
monitor sends in
downloaded EDC web-based EDC
What is the frequency of monitoring visits after first visit? / Minimum of every ______weeks
Are there any special storage requirements for the investigational product or clinical trial materials? / no yes, please explain.
______
______
Are there central or required local labs? / Local, ______
Central – Please provide Lab Manual
Will lab and shipping supplies be provided? / no yes
Will dry ice be required? / no yes, for which visits______
Do you anticipate collecting and keeping any additional samples from subjects for a bio-repository? / 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
Do you require one page CVs in a sponsor form for all study team? / no yes
Provide the record retention requirements for this protocol. / ______years after study completion
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: / Phone number:

OCRSS Sponsor Questionnaire

Version: 6/27/20111 of 5