Form Fda 1572 PDF Details

In the complex landscape of clinical research and investigational drug studies, the Form FDA 1572, also known as the Statement of Investigator form, emerges as a cornerstone document. This key form is a binding agreement, ensuring that investigators conducting research in these realms adhere to a strict set of guidelines and commitments. Its importance cannot be overstated as it helps in maintaining the integrity and the quality of the research, safeguarding participant rights, and ensuring compliance with the U.S. Food and Drug Administration’s (FDA) regulations. When an investigator signs this document, they confirm their qualifications and agree to conduct the study according to the specified protocol, only making changes with the sponsor's notification unless it's to protect participant safety. This form also highlights the researcher's promise to secure informed consent from participants, report adverse experiences, maintain accurate records, and comply with Institutional Review Board (IRB) approvals and reviews. Completing and signing Form FDA 1572 is a prerequisite for investigators before participating in a study, signifying a major step in the preparation phase of any clinical investigation. It meticulously outlines the responsibilities of clinical investigators and encapsulates the essence of ethical and regulatory compliance in clinical research, making it a pivotal document in the pharmaceutical and healthcare research fields.

QuestionAnswer
Form NameForm Fda 1572
Form Length2 pages
Fillable?No
Fillable fields0
Avg. time to fill out30 sec
Other names1572, fda 1572, fda 1572 guidance, form fda 2

Form Preview Example

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Form Approved: OMB No. 0910-0014

Expiration Date: March 31, 2022

 

FOOD AND DRUG ADMINISTRATION

 

 

 

See OMB Statement on Reverse.

 

 

 

 

STATEMENT OF INVESTIGATOR

 

 

 

 

NOTE: No investigator may participate in an

(TITLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART 312)

investigation until he/she provides the sponsor with

 

(See instructions on reverse side.)

 

a completed, signed Statement of Investigator, Form

 

 

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

 

 

 

 

 

 

 

 

FORM FDA 1572 (3/19)

 

PREVIOUS EDITION IS OBSOLETE.

 

 

Page 1 of 2

PSC Publishing Services (301) 443-6740

EF

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 Operations

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 (3/19)

PREVIOUS EDITION IS OBSOLETE.

Page 2 of 2

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Step number 1 in submitting fda statement

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COMMITMENTS, I agree to ensure that all, and For Phase or investigations an of fda statement

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