4 International investigator statement

Form Approved: OMB No. 0925-0613
Expiration Date: 03-31-2022

Collection of this information is for credentialing of investigators for participation in National Cancer Institute protocols. This information may be disclosed to sponsors of clinical trials (if
applicable) or responsible organization, the applicable Institutional Review Board (IRB)/Independent Ethics Committee (IEC), National Cancer Institute, Food and Drug Administration's
Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, and the Department of Health and Human Services. Submission of this information is
voluntary, however, in order to qualify for participation on NCI protocols, you must complete all fields
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA
(0925-0753). Do not return the completed form to this address.

International Investigator Statement
Instructions:This form is used for Non-US investigators to attest that the study(ies) will be conducted according to
International Conference on Harmonisation (ICH) Good Clinical Practice (GCP).
NOTE: No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed International Investigator
Statement Form.
1.

NAME AND ADDRESS OF PRINCIPAL INVESTIGATOR.

2. EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFIES THE INVESTIGATOR. ONE OF THE FOLLOWING IS ATTACHED.
Curriculum Vitae

3.

NAME AND ADDRESS OF FACILITY WHERE THE CLINICAL INVESTIGATION(S) WILL BE CONDUCTED.
CTEP Site Code

4.

Site Name

Site Address

NAME AND ADDRESS OF ANY CLINICAL LABORATORY FACILITIES TO BE USED IN THE STUDY.
CLIA/CAP Number

5.

Other Statement of Qualifications

Lab Name

Lab Address

NAME AND ADDRESS OF THE RESPONSIBLE INSTITUTIONAL REVIEW BOARD(IRB)/ INDEPENDENT ETHICS COMMITTEE(IEC)
IRB Number

IRB Name

IRB Address

6.

NAMES OF THE CO-INVESTIGATORS WHO WILL BE ASSISTING THE PRINCIPAL INVESTIGATOR IN THE CONDUCT OF THE
PROTOCOL(S):

7.

PROTOCOL NUMBER AND TITLE:

8.

COMMITMENTS:
I agree to conduct the protocol(s) in accordance with the relevant documents and will only make changes in a protocol after notifying the
sponsor or responsible organization, 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 (if
applicable) and I will ensure that the requirements relating to obtaining informed consent and Independent Ethics Committee(IEC) review
and approval in ICH E6, national and regional legislation, and the Declaration of Helsinki are met.
I agree to report to the sponsor or responsible organization any adverse experiences that occur in the course of the investigation(s) in
accordance with ICH E6, national and regional legislation, and the Declaration of Helsinki. I have read and understand the information in the
investigator's brochure (if an investigational agent is being used), 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 and to make those records available for inspection in accordance with ICH E6, national
and regional legislation, and the Declaration of Helsinki.
I will ensure that an IEC that complies with the requirements of ICH E6, national and regional legislation, and the Declaration of Helsinki will
be responsible for the initial and continuing review and approval of the clinical investigation. I also agree to promptly repo it to the IEC all
changes on 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 IEC approval, except where necessary to eliminate apparent immediate hazards to human subjects.
(Rev. 31-JUL-2018)

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I agree to comply with all other requirements, regarding obligations of clinical investigators and all other pertinent requirements in ICH E6,
national and regional legislation, and the Declaration of Helsinki.
9. SIGNATURE OF INVESTIGATOR

10. DATE

This is an electronic signature and is the legally binding equivalent to a handwritten signature.

(Rev. 31-JUL-2018)

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