Study Site or Principal Investigator

Title

Name of Practice/Site where Study will be performed

Institution or Organization

Affiliated with

Address where Study will be performed

City

State

Zip Code

Telephone

Fax

Email Address

DOB

Medical License Number

State

Contact Person

Email

Telephone Number

Fax Number

How many studies have you done in the past?

How many studies are you actively enrolling in now?

What percentage of contracted do you enroll on average? 50% 60% 70% 80% 90% Above 90%

How many coordinators do you have?

How many are CCRC certified? Acceptable Human Subjects Protection certificates include academic medical center earned CME, Dunn and Chadwick's Protecting Study Volunteers in Research or http://cme.cancer.gov/c01

Does the PI have certification of training in Human Subjects Protection?

Does the coordinator(s) have certification of training in Human Subject Protection?

Certificates are required for IRB approvals.

Name

Address

Telephone number

Fax number

Email address

Who dispenses the test article?

Are research personnel available to subjects 24 hours a day?

Have you ever had a FDA Audit?' If YES, what year(s) was it done?

Was a 483 issued? If yes - please Fax to 516-470-6903

Please include an electronic version of your current CV.