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 1 of 5 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________________________________ 2 of 5 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 3 of 5 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 4 of 5 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: 5 of 5