Fda 1572 Form Special Condition Consideration Form

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Collection of this information is authorized under 21 CFR 312.53. The primary use is to identify qualified investigators and as experts to participate in clinical investigations at the National Cancer

Institute. This information may be disclosed to researchers for research purposes, sponsors of clinical trials, the applicable Institutional Review Board, 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 to conduct studies in accordance with the relevant regulatory requirements, you must complete all fields.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Form Approved: OMB No. 0925-0613

Expiration Date: 02/28/2013

PUBLIC HEALTH SERVICE

NOTE: No investigator may participate in an

FOOD AND DRUG ADMINISTRATION

STATEMENT OF INVESTIGATOR

investigation until he/she provides the sponsor with

a completed, signed Statement of Investigator,

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

Form FDA 1572 (21 CFR 312.53(c)).

(See instructions on reverse side.)

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 (0925-0613). Do not return the completed form to this address.

1. NAME AND ADDRESS OF INVESTIGATOR.

2. EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFIES THE INVESTIGATOR AS AN EXPERT IN THE CLINICAL INVESTIGATION OF THE

DRUG FOR THE USE UNDER INVESTIGATION. ONE OF THE FOLLOWING IS ATTACHED.

CURRICULUM VITAE

OTHER STATEMENT OF QUALIFICATIONS

3. NAME AND ADDRESS OF ANY MEDICAL SCHOOL, HOSPITAL, OR OTHER RESEARCH FACILITY WHERE THE CLINICAL INVESTIGATION(S) WILL

BE CONDUCTED.

4. NAME AND ADDRESS OF ANY CLINICAL LABORATORY FACILITIES TO BE USED IN THE STUDY.

5. NAME AND ADDRESS OF THE INSTITUTIONAL REVIEW BOARD (IRB) THAT IS RESPONSIBLE FOR REVIEW AND APPROVAL OF THE STUDY(IES).

6. NAMES OF THE SUBINVESTIGATORS (e.g., research fellows, residents, and associates) WHO WILL BE ASSISTING THE INVESTIGATOR IN THE

CONDUCT OF THE INVESTIGATION(S).

N/A – The Cancer Therapy Evaluation Program, National Cancer Institute requires each investigator to submit a separate FDA Form 1572,

CV, Supplemental Investigator Data Form, and Financial Disclosure Form. Information entered in this section will NOT be entered in the CTEP

NCI database.

7. NAME AND CODE NUMBER, IF ANY, OF THE PROTOCOL(S) IN THE IND FOR THE STUDY(IES) TO BE CONDUCTED BY THE INVESTIGATOR.

I am participating in National Cancer Institute-sponsored clinical trials. I understand that this single FDA Form 1572 will cover my participation in all

(one or more) clinical trials under NCI sponsorship (IND and/or funding). I also understand that I am responsible for meeting all the requirements for

clinical trials specified by this signed FDA Form 1572 for EACH NCI clinical trial in which I participate.

PAGE 1 OF 2

FORM FDA 1572 (5/09)

PREVIOUS EDITION IS OBSOLETE.

Created by Electronic Document Services/USDHHS: (301) 443-2454

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