General Site Information
Facility Name
Facility Description
Type of Facility
Hospital
Private practice
Independent research center
SMO/TMO
University
Out-patient surgical
Other
Address1
Address2
City
State
Zip Code
Phone
Primary contact's name/title
Primary contact's phone #
Fax
Pager or after hours contact
Primary contact's Fax #
Website
E-mail
Principal Investigators Information
Principal Investigator’s Name
Professional Affiliations
Board Certified?
---Select One---
Yes
No
Board Specialty (list all)
Number of years as PI
Sub-Investigator’s Name (list all)
Sub-investigator's specialty (list all)
Additional Site Information
No. of Physicians in Practice
Est. No. of Referring Physicians
General office hours
Can site extend hours if protocol requires
Yes
No
Overnight facilities on-site or through an affiliate site
Yes
No
Laboratory on-site
Yes
No
Can your site utilize a central laboratory
Yes
No
Is there a secured and safe location to store study drugs?
Yes
No
Dedicated monitoring area
Yes
No
Internet Access for Monitors
Yes
No
Available storage conditions
Ambient
Refrigerated
-20C
-70C
Access to dry ice
Yes
No
Shipping available
FEDEX
Less than 1 month
0-3 months
UPS
DHL
4-12 months
1 year or more
I don't know
Other
Closest airport(s) or other transit
Distance, mi
Name of contracts coordinator
Contact information for contracts coordinator
Turnaround time for contracts and regulatory documents
Overhead charges
% of charges
Flat Fee
Additional fees at startup
Yes
No
% of charges
$ amount
Regulatory Profile
IRB utilized
Central
Local
Local IRB Name
If Local, how often do they meet?
Weekly
Bi-monthly
Monthly
Monthly
Other
How far in advance must study materials be received for review?
Average turnaround time for IRB
Cost for IRB review
Initial $
Amendments
Is other board review required (i.e. Scientific Review, Ethics, Privacy, etc.)
Yes
No
Previously audited by FDA?
Yes
No
If yes, issued a FDA 483?
Yes
No
If yes, define major deficiency?
Status of deficiency?
Resolved
Open- response under FDA review
Has the investigator been disqualified?
Yes
No
If yes, when will investigator be reinstated
Clinical Trials Experience and Relevant Expertise
Conducted clinical studies before?
Yes
No
If yes, how many years?
Type of drug products (check all that apply)
Device
Drug
Biologic
Vaccine
Other
Clinical Trials Experience and Relevant Expertise (continued)
Clinical research interests (list all)
Addiction/ Substance Abuse
Tv
Radio
Allergy
Anti-infectives/ infectious disease
Internet
Newspaper
Autoimmune diseases
Cardiology/Vascular Diseases
Cosmetology
CNS
Dental/Maxillofacial Surgery
Dermatology
Emergency Medicine/Trauma
Endocrinology
Family Medicine
Gastroenterology
Geriatrics
Hematology
Hepatology
Immunology
Internal Medicine
Medical Devices
Men's Health
Neurology
Nephrology
Obstetrics/Gynecology
Oncology
Ophthalmology
Orthopedics
Otolaryngology
Pain Management
Pediatrics/Neonatology
Pharmacology/Toxicology including PK/PD/BE/BA studies
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Sleep Disorders
Sports Medicine
Surgery
Transplantation
Urology
Vaccines
Weight Management
Women's Health
Clinical Trials Experience and Relevant Expertise (continued)
Experience by phase of study (check all that apply)
Phase I
Phase II
Phase III
Phase IV
Other
Number of patients seen per month that would be candidates for participation in clinical studies?
Is there a full-time study coordinator?
Yes
No
Total number of study coordinators?
Study coordinator's range of years of experience?
List any additional support staff (laboratory, phlebotomy, recruitment specialist etc.)
Method(s) used for patient recruitment (Check all that apply)
Patient Database
Phone
Text
Advertising
Referrals
Email
Health Fairs
Patient Recruitment Firm
Other
Name of Individual Completing Survey
Title
Date
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