Investigator Profile
Complete the following information for the physician who will act as Principal Investigator for this study.
Investigator Name:
Date of birth:
Medical license #:
Licensed in which state(s)?
Mailing address:
Office Name:
Address line 1:
Office phone:
Address line 2
Fax number:
City
Pager:
State:
Access to Internet?
Zip
No
Country
Extension:
ID#:
Email address:
Yes
How often does this email get checked?
More than once a day
Daily
Weekly
Less than once a week
Check one specialty that applies to this Investigator:
Allergy & Immunology
Anesthesia
Cardiology
Cardiothoracic Surgery
Chelation
Dermatology
Emergency Medicine
Endocrinology
Gastroenterology
General Surgery
Genetics
Gerontology
Hematology
Infectious Disease
Internal Medicine
Nephrology
CNS
Oncology
Ophthalmology
Orthopedics
Otolaryngology
What age group(s) do you see for this specialty (check all that apply)?
Neonatal
Adult
Pediatrics
Primary Care
Psychiatry
Psychology
Pulmonology
Rheumatology
Urology
Women’s Health
Pediatric
Geriatric
Adolescent
Investigator research training certification(s):
NIH (Human Subject Protection)
ACRP (Association of Clinical Research Professionals)
Investigator clinical research experience:
New to Research
1 – 5 years
What percentage of this Investigator’s practice time is devoted to research?
5 or more years
%
Site Management Organization (SMO) or Consortium through which clinical research is conducted (if applicable):
Name:
Acronym:
Page 1 of 5
Study Coordinator Profile
Complete the following information for the individual who will act as PRIMARY Study Coordinator (SC)
Do you have a Primary Study Coordinator?
Is Study Coordinator
Full Time
No  If No, skip to page 3.
Yes
Part Time
Will the Primary Study Coordinator enter data into the Electronic Data Collection System?
Yes
No
If No, list the name of the person who will complete this task:
Name of person who will administer and monitor chelation infusions:
Has this person been previously trained in chelation therapy administration?
Yes
No
If No, does this person expect to receive chelation therapy administration training at the TACT
Investigator Meeting?
Yes
No
SC Name:
Degree
Office #1 phone:
Extension:
Office #2 phone:
Extension:
Fax number:
Pager:
ID#:
Email address:
How often does this email get checked?
More than once a day
Daily
Access to Internet?
No
Weekly
Less than once a week
Yes
Mailing address:
Express courier address (if different):
Office name:
Office name:
Address line 1:
Address line 1:
Address line 2:
Address line 2:
City:
City:
State:
Zip:
Country:
Study Coordinator clinical research experience:
State:
Zip:
Country:
New to Research
1 – 5 years
5 or more years
Study Coordinator research training certification(s):
NIH (Human Subject Protection)
ACRP (Association of Clinical Research Professionals
SoCRA (Society of Clinical Research Associates)
Other:
Page 2 of 5
Associated Hospital Information
(if applicable)
Hospital name:
Main phone:
Extension:
Phone #2:
Extension:
Fax number:
Check one:
University Medical Center
Check all that apply:
Medical Residency On Site
Specify Academic Affiliation
VA/Public Health Medical Center
Private funded
Community Medical Center
Public funded
Main Hospital Mailing address:
Address line 1:
Address line 2:
City:
State:
Zip:
Country:
Institutional Review Board (IRB) Information
IRB name:
Is this IRB
Hospital IRB
Central IRB (independent from a hospital)
Is there a charge to review protocols?
Frequency of meetings:
Annual
No
Semi-annual
Average time from IRB Submission to IRB Approval:
Yes  If Yes, amount: $
Quarterly
Less than 1 month
Monthly
Weekly
1 – 2 months
As needed
More than 2 months
Page 3 of 5
Practice/Clinic Information
Complete the following information for the practice/clinic where patient visits and/or chelation will be
performed. (Please provide complete proper name of practice or organization)
Practice/Clinic Name:
Is this a multi-specialty practice?
No
Yes
Practice Mailing address:
Address line 1:
Address line 2:
City:
State:
Zip:
Country:
Chelation Site Location (If Different from Clinic Location):
Contact Name:
Chelation Site Mailing address:
Office name:
Phone:
Ext
Address line 1:
Fax:
Ext
Address line 2:
Pager:
City:
Email Address:
State:
Country:
Zip:
How often does this email get checked?
More than once a day
Weekly
Daily
Less than once a week
Page 4 of 5
Investigational Product Shipment Information
Complete the following information for the PERSON RESPONSIBLE FOR RECEIPT OF
INVESTIGATIONAL PRODUCT (drug, device, etc.).
Name:
Title:
Phone:
Extension:
Fax:
Email:
Delivery address (cannot use P.O. Box):
Office name:
Address line 1:
Address line 2:
City:
State:
Is this a pharmacy?
No
Zip:
Yes  If Yes, is this a 24-hour pharmacy?
Can test article shipments be received on Saturday?
No
Country:
No
Yes
Yes
Completed by:
Date completed:
Role:
Complete this form electronically and forward as an email attachment,
Or Complete, Print and Fax
Send the completed form to
Brian Fox, CTA
Email: fox00019@mc.duke.edu
Fax: (919) 668-7008
Page 5 of 5