FORM FDA 1572

Transcript

1 Form Approved: OMB No. 0910-0014 DEPARTMENT OF HEALTH AND HUMAN SERVICES , 20 22 Expiration Date: March 31 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 Clinic al Investigator Address 1 Address 2 State/Province/Region Country ZIP or Postal Code City AND EXPERIENCE 2. EDUCATION, TRAINING, AS AN EXPERT IN THE CLINICAL INVESTIGATION OF QUALIFY THE INVESTIGATOR THAT one of the following.) (Select THE DRUG FOR THE USE UNDER INVESTIGATION. ONE OF THE FOLLOWING IS PROVIDED Other Statement of Qualifications Curriculum Vitae ANY MEDICAL SCHOOL, HOSPITAL, OR OTHER RESEARCH FACILITY 3. NAME AND ADDRESS OF CONTINUATION PAGE for Item 3 WHERE THE CLINICAL INVESTIGATION(S) WILL BE CONDUCTED Name of Medical School, Hospital, or Other Research Facility Address 1 Address 2 Country ZIP or Postal Code City State/Province/Region ANY CLINICAL LABORATORY FACILITIES 4. NAME AND ADDRESS OF 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 for Item 5 REVIEW AND APPROVAL OF THE STUDY(IES) Name of IRB Address 2 Address 1 City State/Province/Region Country ZIP or Postal Code (If not applicable, enter “None”) 6. NAMES OF SUBINVESTIGATORS 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PROTOCOL(S) IN THE IND FOR THE STUDY(IES) TO BE CONDUCTED BY THE INVESTIGATOR FORM FDA 1572 ( 3 /1 9 ) PREVIOUS EDITION IS OBSOLETE. Page 1 of PSC Publishing Services (301) 443-6740 EF

2 (Select of the following.) 8. PROVIDE THE FOLLOWING CLINICAL PROTOCOL INFORMATION. one 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. COMMITMENTS 9. 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 Complete all sections. Provide a separate page if additional space is needed. 1. 2. Provide curriculum vitae or other statement of qualifications as described in Section 2. 3. Provide protocol outline as described in Section 8. Sign and date below. 4. FORWARD THE COMPLETED FORM AND OTHER DOCUMENTS BEING PROVIDED TO THE SPONSOR. The sponsor will 5. incorporate this information along with other technical data into an Investigational New Drug Application (IND). INVESTIGATORS TO THE FOOD AND DRUG ADMINISTRATION. THIS FORM DIRECTLY SEND SHOULD NOT 11. SIGNATURE OF INVESTIGATOR (mm/dd/yyyy) 10. DATE 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. Department of Health and Human Services The burden time for this collection of information is estimated to average 100 hours per Food and Drug Administration response, including the time to review instructions, search existing data sources, gather Operations Office of and maintain the data needed and complete and review the collection of information. Send Paperwork Reduction Act (PRA) Staff comments regarding this burden estimate or any other aspect of this information collection, [email protected] including suggestions for reducing this burden to the address to the right: DO NOT SEND YOUR COMPLETED FORM “An agency may not conduct or sponsor, and a person is not required to respond to, a TO THIS PRA STAFF EMAIL ADDRESS. collection of information unless it displays a currently valid OMB number.” FORM FDA 1572 ( 3/19 ) PREVIOUS EDITION IS OBSOLETE. Page 2 of

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