Form Fda-1572 - Statement Of Investigator printable pdf download

Form Fda-1572 - Statement Of Investigator

Form Approved: OMB No. 0910-0014

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Expiration Date: April 30, 2015

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 Principal 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

FORM FDA 1572 (7/13)

PREVIOUS EDITION IS OBSOLETE.

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Form Fda-1572 - Statement Of Investigator

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