Statement Of Investigator
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2Form Approved: OMB No. 0910-0014
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Expiration Date: February 28, 2019
FOOD AND DRUG ADMINISTRATION
See OMB Statement on Reverse.
STATEMENT OF INVESTIGATOR
NOTE:
No investigator may participate in an
investigation until he/she provides the sponsor with
(TITLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART 312)
a completed, signed Statement of Investigator, Form
(See instructions on reverse side.)
FDA 1572 (21 CFR 312.53(c)).
1. NAME AND ADDRESS OF INVESTIGATOR
Name of Clinical Investigator
Address 1
Address 2
City
State/Province/Region
Country
ZIP or Postal Code
2. EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFY THE INVESTIGATOR AS AN EXPERT IN THE CLINICAL INVESTIGATION OF
THE DRUG FOR THE USE UNDER INVESTIGATION. ONE OF THE FOLLOWING IS PROVIDED (Select one of the following.)
Curriculum Vitae
Other Statement of Qualifications
3. NAME AND ADDRESS OF ANY MEDICAL SCHOOL, HOSPITAL, OR OTHER RESEARCH FACILITY
CONTINUATION PAGE
WHERE THE CLINICAL INVESTIGATION(S) WILL BE CONDUCTED
for Item 3
Name of Medical School, Hospital, or Other Research Facility
Address 1
Address 2
City
State/Province/Region
Country
ZIP or Postal Code
4. NAME AND ADDRESS OF ANY CLINICAL LABORATORY FACILITIES TO BE USED IN THE STUDY
CONTINUATION PAGE
for Item 4
Name of Clinical Laboratory Facility
Address 1
Address 2
City
State/Province/Region
Country
ZIP or Postal Code
5. NAME AND ADDRESS OF THE INSTITUTIONAL REVIEW BOARD (IRB) THAT IS RESPONSIBLE FOR
CONTINUATION PAGE
REVIEW AND APPROVAL OF THE STUDY(IES)
for Item 5
Name of IRB
Address 1
Address 2
City
State/Province/Region
Country
ZIP or Postal Code
6. NAMES OF SUBINVESTIGATORS (If not applicable, enter “None”)
CONTINUATION PAGE – for Item 6
7. NAME AND CODE NUMBER, IF ANY, OF THE PROTOCOL(S) IN THE IND FOR THE STUDY(IES) TO BE CONDUCTED BY THE INVESTIGATOR
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FORM FDA 1572 (2/16)
PREVIOUS EDITION IS OBSOLETE.
Page 1 of
EF
PSC Publishing Services (301) 443-6740
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