Site Selection Questionnaire

SITE SELECTION QUESTIONNAIRE

Protocol No.:

Protocol Title:

YOUR NSLIJHS PROGRAM OR COMPANY NAME is currently assessing the feasibility of conducting the above-reference study. In keeping with Guidance for Industry GCP E6, adequate resources need to be confirmed. Investigators should be able to demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period, have sufficient time to properly conduct and complete the trial within the agreed trial period, and have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely. This questionnaire will assist in providing us with information about your investigator(s) and research site to determine, in part, if adequate resources exist at your site to conduct the above-referenced study.

We would appreciate it if you would take a few moments to complete the attached questionnaire. All information you provide will be strictly confidential and will be held internally at YOUR NSLIJHS PROGRAM OR COMPANY NAME. This Clinical Trial is planned to begin in STATE MONTH/YEAR. We would appreciate receiving your completed questionnaire as soon as possible. We sincerely thank you for your time and your interest.

Please complete as much information on the questionnaire as possible (estimates are fine) and fax or e-mail to:

CONTACT NAME

TITLE

YOUR PROGRAM OR COMPANY NAME

Phone:

Fax:

E-mail:

PRINCIPAL INVESTIGATORPROFILE

Name: / Title(s):
Degree(s) / Certification(s):
Institution Name:
Department/ Division:
Address:
Phone: / Fax:
Email: / Website:
Therapeutic Specialty: / Are you Board Certified in this specialty? Yes No
Sub-Specialty: / Are you Board Certified in this sub-specialty? Yes No

Resources and Research Experience

How many studies are you currently conducting?

How many studies are you planning to conduct between and ?

Of these studies, how many directly compete for patients with the target population?

How many industry-sponsored studies have you conducted in <area of interest> ?
How many years of experience do you have in conducting clinical trials?
If “Yes,” please provide the name and date of the most recent study:

Type of Site (please check all that apply):

AcademicMedicalCenterRehabilitation Hospital/Clinic

ConsortiumResearchHealthCenter

Group: Multi-specialtySolo Practice

Group: Single specialtyStudentHealthCenter

Hospital BasedSurgical Center

Mental Health Hospital/ClinicUniversityHospital

Military Hospital/ClinicVA

Private PracticeOther (List):

Drug / Biologic Phase Experience (please check all the apply):

Study Type / Therapeutic Area
(e.g. Rheumatology) / Indication
(e.g. RA, SLE) / # of Drug / Biologic Trials Conducted / Study Status
(e.g. currently enrolling, closed to enrollment, terminated/closed)
Phase I
Phase II
Phase III
Phase IV
Other:

Device Phase Experience (please check all the apply):

Study Type / Therapeutic Area
(e.g. Rheumatology) / Indication
(e.g. RA, SLE) / # of Device Trials Conducted / Study Status
(e.g. currently enrolling, closed to enrollment, terminated/closed)
Pilot
Post-Marketing
Registry / Pivotal

Does your Site Have the Following Facilities / Equipment / Abilities?

SOPs for Clinical Research Yes No

Secure Record Storage Yes No

Secure Drug / Device Storage Yes No

Research Pharmacy Yes No

Refrigerator Yes No

Freezer (-20°C) Yes No

Freezer (-80°C) Yes No

Cardiac Stress Testing Yes No

Clinical Lab Yes No

Micro Lab Yes No

Cath Lab Yes No

Central lab access Yes No

Ultrasound Yes No

Centrifuge Yes No

Radiology Yes No

Angiography Yes No

Access to ER Yes No

ECG Yes No

Inpatient Yes No

Outpatient Yes No

Yes No

Yes No

Yes No

YesNo

Yes No

Yes No

Please list all Hospital Affiliations:

PRIOR INSPECTIONS

Has your site ever been audited by a regulatory agency? Yes No

If “Yes,” which one?

If “Yes,” when did the audit occur?

Have you ever received a 483 or warning letter from the FDA? Yes No

Local Area Information

What is the closest airport to your site?
On average, how long does it take to drive to your site from the closest airport? hours minutes

STAFF & SITE PROFILE

Lead Study Coordinator or Research Manager:

Name: / Title(s):
Degree(s) / Certification(s):
Institution Name:
Department/ Division:
Address: Same address as PI. / Current Status:
Full time
Part-time
Per-Diem
Phone: / Fax:
Email:
How many years have you been conducting clinical research?
How many full-time coordinators do you presently have working on clinical trials at your site?
How many trials does each coordinator typically work on at any given time?
How many certified coordinators are on staff?
How many part-time coordinators?

Research Team:

How many members of your research team do you expect to be part of your study team for this study?
Of these investigators, how many have received human subjects training (HST)? #specify HST received:

PATIENT PROFILE AND RECRUITMENT

Approximate number of patients seen in your site:
Approximate number of visits per year:
Approximate % of patients that are:
Pediatric (infant – 12 yrs.) % Adolescent (13 – 17 yrs.)% Other : %
Adult (18 – 64 yrs.) % Geriatric (64 yrs. and older)% Other : %
Given the inclusion/exclusion criteria and the proposed study design, how many subjects do you estimate you could randomize into the study?
subjects in 1 month subjects in 12 months
What recruitment methods would you consider to increase enrollment at your site?
Internet/Electronic Recruitment
Social networking sites (e.g. Facebook, Twitter, MySpace)
Internet listings of clinical trials (e.g. Craigslist, CenterWatch.com)
Internet basic trial information (e.g. ClinicalTrials.gov)*
Direct Contact
In person or via telephone by the PI or his/her designee
Indirect Contact
Word-of-mouth
Referral from an outside investigator or physician
Chart/database review
Review of chart/database
Printed Advertisements/Recruitment Methods
Study-specific letter to local physicians
Study-specific letter to patient or past subjects
Flyers
Posters / Pamphlets
Brochures
Newspaper
Postcards
Audio-Visual Recruitment
Audio/video tape, radio, television
Other recruitment method(s)
Specify,

INFORMED CONSENT

Process
Describe the consent process starting from initial contact with subjects:
Describe the documentation of the consent process by the investigator:
Do you use consent review quizzes? Yes No
Do you use a witness to the signature or consent process? Yes No
If so, who to you ask to be the witness?
Foreign Language
Do you expect to enroll subjects who are not fluent in English? Yes No
If so, which language might be used to consent subjects?
Alternative Consent Methods
Do you use any alternative consent methods to obtain consent (e.g. phone, mail, fax, email)? If yes, describe process:
Capacity
Do all of your subjects have the capacity to consent? Yes No
If no, describe process used to ascertain capacity:
Consent Quiz Mini-Mental Test Clinical Interview Other:
If using process (such as quiz), describe process if they fail:

IRB PROFILE

What is Your Site’s IRB Requirement? Central Local
If “Local,” Name of IRB:
If “Local,” Frequency of Meetings (in weeks):
If “Local,” Are there additional levels of review (i.e. Scientific, Dept. Review, etc.)? Yes No

ELECTRONIC DATA CAPTURE (EDC) PROFILE

Does your site have EDC experience?YesNo
If “Yes,” please indicate the company / vendor(s):
Are you currently conducting any EDC trials? YesNo
If “Yes,” how many?:
Does your site have a dedicated computer for the EDC system? YesNo
Does your site have a dedicated EDC entry person? YesNo
Do you have high-speed internet access?YesNo
Do you have a way for the Monitor to access the internet? YesNo
Does your site have IT support available?YesNo
What operating system does your computer system use? Windows WinXP Mac OSX
Other (specify):
What Internet browser does your site use?
Internet Explorer please specify version:Netscape Firefox
Other (specify):
Does your staff have email access? Yes No

Do you have any colleagues who might be interested in participating in the conduct of this study? If so, please provide their contact information below:

Name:
Address:
Phone:
Fax:
Email:
Therapeutic Specialties:

Person Completing the Questionnaire: Phone: Email:

Thank you for your interest!

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