Principle Investigator & Site Questionnaire

JANIX, LLC Clinical Site Information
Questionnaire

Investigator Name:

MD DO Board Certified

Speciality:

Institution Name:

Institution Address:

Our Insitution is:
Academic	Private	SMO
VA	Military	Other

Investigator Phone:

Investigator Email:

Investigator Fax:

SC Name:

Study Coordinator (SC):

SC Phone:

SC Email:

SC Fax:

RC Name:

Regulatory Coordinator (RC):
Person who handles Regulatory Documents. If N/A please leave blank

RC Phone:

RC Email:

RC Fax:

CTA Name:

CTA Contact:
Person who handles budget and/or contract negotations

CTA Phone:

CTA Email:

CTA Fax:

Other Name:

"Other"
Person other than the SC, RC or CTC that may have involvement, as appropriate

Other Phone:

Other Email:

Other Fax:

Is a Scientific Review Board or Other Pre-IRB Board Review Required?

YES - Complete Pre-IRB review information below:
NO - Skip to next question

Pre-Review Submission Lead Time:

Frequency of Meetings:

Time from Approval to IRB Submission:

Can your institution use a CENTRAL IRB?

YES - Skip to next question
NO - Provide LOCAL IRB Details below:

LOCAL IRB Initial Review Fee:

LOCAL IRB "Annual" Review Fee:

LOCAL IRB Submission Lead Time:

LOCAL IRB Frequency of Meetings:

LOCAL IRB Time for Approval Letter:

Does your institution require POST IRB Approval (ie, Institution Approval) ?

YES - Skip to next question
NO - Provide Details below:

POST IRB Submission Lead Time:

POST IRB Frequency of Meetings:

POST IRB Time to Approval Letter:

Other Requirement - Please enter your comments below: Enter your comments here

Send Budget Template to: PI SC RC Other

Average weeks from Budget receipt to finalization?

Send Template Contract to: PI SC RC Other

Average weeks from Contract receipt to finalization:

Does your site Require an Insurance Certificate and/or Identification? Yes No

Does your institution have satelite offices? Yes No - if "Yes" enter number of offices:

Which days of the week are patients seen?
Normal Clinic Hours:

# of SC(s) working on Research:		% SC Time to Research:
Approx. # of Students EACH SC is assigned:		% time PI allocates to Research:
# Years Experience as PI:		# of Sub-I's in Practice:

Will Investigation Product be stored in a Pharmacy? Yes No

Has the FDA ever Audited your site?: Yes No

What methods does the site use to recruit patients?:

Advertising Health Fairs Outreach Meetings INTERNAL Colleagues
Neighboring Physicians Patient Database

Please list the LAST 3 Studies COMPLETED

Indication	Enrollment Goal	# Actual Screened	# Actual Randomized	# Actual Completed	Enrollment Length	Length of Follow-Up






Thank You very much for your interest to participate in a future JANIX clinical study JANIX, LLC 1200 Quail Street, Suite 170 Newport Beach, CA 92660 USA www.Janix.com General Phone # +1-949-251-9800 Fax # +1-949-474-0178

JANIX, LLC Clinical Site Information Questionnaire

JANIX, LLC Clinical Site Information
Questionnaire