RESEARCH SITE QUESTIONNAIRE

Complete one Research Site Questionnaire for EACH site where your study will be conducted as listed in box #3 of the form FDA 1572 or equivalent for this study. Blank or incomplete answers will result in delayed reviews.

Site Name:
/ Principal Investigator:
Address:
City: / State: / Zip:
Contact Name: / Phone No.: ()- / Fax No.: ()-
Check here if this is your first time submitting a Research Site Questionnaire.
Check here if this is an update or a change to a previously submitted Research Site Questionnaire.

RESEARCH FACILITY INFORMATION

1. How long has your site been conducting research?
2. How many studies have you conducted in the past year at this site?
3. What is the total number of research staff?
4. Please check all the study activities that will be conducted at this facility:
Administrative Activities Informed Consent Discussion Study Visits
Specialized Procedures Other:
5. Please indicate the type of facility:
Medical Office University Hospital Other:
2525 Camino del Rio South / Phone: (619) 282-9997
Suite 300 / Fax: (619) 282-9998
San Diego, CA 92108 / E-mail:
Research Site Questionnaire / Page 1 of 2 / Revision Date: 07/01/04

RESEARCH SITE QUESTIONNAIRE

EMERGENCY MEASURES

2525 Camino del Rio South / Phone: (619) 282-9997
Suite 300 / Fax: (619) 282-9998
San Diego, CA 92108 / E-mail:
Research Site Questionnaire / Page 1 of 2 / Revision Date: 07/01/04

RESEARCH SITE QUESTIONNAIRE

6. Please mark the emergency equipment you have on site to manage serious adverse events or life threatening
situations:
CPR certified personnel
Benadryl
Epinephrine
Oxygen
Access 911
/ Crash Cart
(A Crash Cart is defined as a workstation that contains drugs, supplies and equipment used for the medical purpose of treating a cardiopulmonary emergency.)
Other:

ADDITIONAL QUESTIONS

7. How often does the Principal Investigator see the study subjects?
First/Last Visits / As Protocol Indicates / Only when requested / Other:
8. Who will discuss the Informed Consent with potential subjects for this study?
Principal Investigator Sub-Investigator Study Coordinator Research Site Coordinator
9. Please describe your procedure for presenting the informed consent to the study subjects. If minors or non-readers
are involved, please document assent procedure.
(Describe below or attach copy).
10. Please check the applicable boxes or (otherwise provide explanation):
Ask questions and receive answers regarding the study
Read consent at home before deciding to participate in study
Take their time to decide whether or not to participate in the study
Name of Person Completing this Submittal / Date
Signature of Person Completing this Submittal
2525 Camino del Rio South / Phone: (619) 282-9997
Suite 300 / Fax: (619) 282-9998
San Diego, CA 92108 / E-mail:
Research Site Questionnaire / Page 1 of 2 / Revision Date: 07/01/04