Form Fda-1572 - Statement Of Investigator (Page 2 of 2) in pdf

8. PROVIDE THE FOLLOWING CLINICAL PROTOCOL INFORMATION. (Select one of the following.)

For Phase 1 investigations, a general outline of the planned investigation including the estimated duration of the study and the

maximum number of subjects that will be involved.

For Phase 2 or 3 investigations, an outline of the study protocol including an approximation of the number of subjects to be

treated with the drug and the number to be employed as controls, if any; the clinical uses to be investigated; characteristics

of subjects by age, sex, and condition; the kind of clinical observations and laboratory tests to be conducted; the estimated

duration of the study; and copies or a description of case report forms to be used.

9. COMMITMENTS

I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after

notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.

I agree to personally conduct or supervise the described investigation(s).

I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will

ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) review

and approval in 21 CFR Part 56 are met.

I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR

312.64. I have read and understand the information in the investigator’s brochure, including the potential risks and side effects of the

drug.

I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their

obligations in meeting the above commitments.

I agree to maintain adequate and accurate records in accordance with 21 CFR 312.62 and to make those records available for

inspection in accordance with 21 CFR 312.68.

I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing

review and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all

unanticipated problems involving risks to human subjects or others. Additionally, I will not make any changes in the research without

IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.

I agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in

21 CFR Part 312.

INSTRUCTIONS FOR COMPLETING FORM FDA 1572

STATEMENT OF INVESTIGATOR

1. Complete all sections. Provide a separate page if additional space is needed.

2. Provide curriculum vitae or other statement of qualifications as described in Section 2.

3. Provide protocol outline as described in Section 8.

4. Sign and date below.

5. FORWARD THE COMPLETED FORM AND OTHER DOCUMENTS BEING PROVIDED TO THE SPONSOR. The sponsor will

incorporate this information along with other technical data into an Investigational New Drug Application (IND). INVESTIGATORS

SHOULD NOT SEND THIS FORM DIRECTLY TO THE FOOD AND DRUG ADMINISTRATION.

10. DATE (mm/dd/yyyy)

11. SIGNATURE OF INVESTIGATOR

Sign

(WARNING: A willfully false statement is a criminal offense. U.S.C. Title 18, Sec. 1001.)

The information below applies only to requirements of the Paperwork Reduction Act of 1995.

The burden time for this collection of information is estimated to average 100 hours per

Department of Health and Human Services

response, including the time to review instructions, search existing data sources, gather

Food and Drug Administration

and maintain the data needed and complete and review the collection of information. Send

Office of Chief Information Officer

comments regarding this burden estimate or any other aspect of this information collection,

Paperwork Reduction Act (PRA) Staff

including suggestions for reducing this burden to the address to the right:

PRAStaff@fda.hhs.gov

“An agency may not conduct or sponsor, and a person is not required to respond to, a

DO NOT SEND YOUR COMPLETED FORM

collection of information unless it displays a currently valid OMB number.”

TO THIS PRA STAFF EMAIL ADDRESS.

FORM FDA 1572 (7/13)

PREVIOUS EDITION IS OBSOLETE.

Page 2 of

Form Fda-1572 - Statement Of Investigator Page 2

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