Site Feasibility Questionnaire

Ophthalmology Research Study Initial Site Assessment/Feasibility Questionnaire

Please provide the requested information so that we may assess the potential for your participation in upcoming studies. By responding to this survey it does not confirm your selection as a study site. Study site selection will be confirmed via additional required steps, which will be discussed with you following review your survey responses. Thank you in advance for taking the time to complete this questionnaire, in general this questionnaire takes approximately 20 minutes to complete.

If you have any technical difficulties or if you have any questions or concerns with this questionnaire, please contact Holly Lorentz at hlorentz@inflamaxresearch.com or (905) 282-1808 ext. 2263.

Site Information
Is your site interested in conducting clinical research trials?


Would you like us to keep your name / information on file?


Can we contact you in 1 year to update this information?








Name of the person completing this questionnaire:
Role of the person completing this questionnaire:
Email address & phone number of the person completing this questionnaire: Email Address
Phone Number
Name of the site or institution:
Type of site:
 Private Ophthalmology Practice  Hospital
 University Centre  Contract Research Organization
 Private Optometry Practise
(Do you have an affiliation with an Ophthalmologist who can act as PI for Applicable Studies )
If Yes, name of the Ophthalmologist
 Other (please specify)
Is your site affiliated with a hospital or University?
If Yes, name of hospital or University?


CONFIDENTIAL

1310 Fewster Drive, Mississauga, Ontario, L4W 1A4 Canada

Tel: 905 282 1808 Fax: 905 206 2690 Toll Free: 1 888 989 1808

www.inflamaxresearch.com

Sub-Investigator (1) +
Name of Sub-Investigator
Degree  MD OD DO PhD  Other
Speciality and Sub-Specialties:
Board Certification:
Years of Clinical Research Experience
Does the Sub-Investigator have documented GCP training?
Number of studies served as Sub-Investigator:
Number and Phase of studies served as Sub-Investigator per Indications:
(Indication example: dry eye, ocular allergy, macular degeneration etc)

% of time currently spent on clinic research trials
What is your preferred clinical trial interest area? (Indication and Phase?)
Sub-Investigator (2) +
Name of Sub-Investigator
Degree  MD OD DO PhD  Other
Speciality and Sub-Specialties:
Board Certification:
Years of Clinical Research Experience
Does the Sub-Investigator have documented GCP training?
Number of studies served as Sub-Investigator:
Number and Phase of studies served as Sub-Investigator per Indications:
(Indication example: dry eye, ocular allergy, macular degeneration etc)
% of time currently spent on clinic research trials
What is your preferred clinical trial interest area? (Indication and Phase?)
Sub-Investigator (3) +
Name of Sub-Investigator
Degree  MD OD DO PhD  Other
Speciality and Sub-Specialties:
Board Certification:
Years of Clinical Research Experience
Does the Sub-Investigator have documented GCP training?
Number of studies served as Sub-Investigator:
Number and Phase of studies served as Sub-Investigator per Indications:

(Indication example: dry eye, ocular allergy, macular degeneration etc)
% of time currently spent on clinic research trials
What is your preferred clinical trial interest area? (Indication and Phase?)
Sub-Investigator (4) +
Name of Sub-Investigator
Degree  MD OD DO PhD  Other
Speciality and Sub-Specialties:
Board Certification:
Years of Clinical Research Experience
Does the Sub-Investigator have documented GCP training?
Number of studies served as Sub-Investigator:
Number and Phase of studies served as Sub-Investigator per Indications:

(Indication example: dry eye, ocular allergy, macular degeneration etc)
% of time currently spent on clinic research trials
What is your preferred clinical trial interest area? (Indication and Phase?)
Sub-Investigator (5) +
Name of Sub-Investigator
Degree  MD OD DO PhD  Other
Speciality and Sub-Specialties:
Board Certification:
Years of Clinical Research Experience
Does the Sub-Investigator have documented GCP training?
Number of studies served as Sub-Investigator:
Number and Phase of studies served as Sub-Investigator per Indications:

(Indication example: dry eye, ocular allergy, macular degeneration etc)
% of time currently spent on clinic research trials
What is your preferred clinical trial interest area? (Indication and Phase?)
Clinical Research Staff Information
Do you have the clinical research staff:
Research staff title, education, training and experience:
(Examples: clinical research coordinator, COT, RN, LPN, BA, BS, research manager, pharmacist etc.)
Title :
Education :
Training :
Years of clinical research experience :
Experience with electronic data capture :


Title :
Education :
Training :
Years of clinical research experience :
Experience with electronic data capture :


Title :
Education :
Training :
Years of clinical research experience :
Experience with electronic data capture :
General Site Information
Do you have access to -70C or -80C freezer?

If Yes, do you have way to monitor temperature in this freezer?


Are your freezer/refrigerators or any other equipment attached to a back-up generator?
Do you have site staff that has experience with blood collection that involves centrifugation and transfer of aliquots?


If Yes, how many staff and what are their degree/training?


If Yes, do you have access to centrifuge?

If No, do you work with a local lab that can perform blood draws, preparation and transfer of samples to a central lab?




# of staff
Degree / Training





Does your site have personnel that are familiar with shipping biological study samples with dry ice and are currently IATA (International Air Transport Association) certified?
Have you or your site been audited by the FDA or any other regulatory agency in past 10 years?

If Yes, was a 483 issued?


Have you or anyone at your site been debarred by FDA or Health Canada from conducting clinical studies?
What type of IRB do you use?
How often does the IRB committee meet?
What is the turnaround time for IRB review and approvals?
Beyond the basic ophthalmology equipment (i.e. slitlamp, tonometry, visual acuity etc.) do you have any specified equipment, imaging system, techniques or procedures at your site (e.g. OCT, impression cytology etc.)?
If Yes, please list equipment and procedures available at your clinic?


Speciliaze equipment/procedures:



Comments :