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| Content | FORM FDA 1572 (5/06)PREVIOUS EDITION IS OBSOLETE.PAGE 1 OF 2 Form Approved: OMB No. 0910-0014. Expiration Date: May 31, 2009. See OMB Statement on Reverse.FOOD AND DRUG ADMINISTRATION STATEMENT OF INVESTIGATOR 3. NAME AND ADDRESS OF ANY MEDICAL SCHOOL, HOSPITAL, OR OTHER RESEARCH FACILITY WHERE THE CLINICAL INVESTIGATION(S) WILL BE CONDUCTED. 1. NAME AND ADDRESS OF INVESTIGATOR NOTE:No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572 (21 CFR 312.53(c)). 6. NAMES OF THE SUBINVESTIGATORS(e.g., research fellows, residents, associates)WHO WILL BE ASSISTING THE INVESTIGATOR IN THE CONDUCT OF THE INVESTIGATION(S). 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 ATTACHED. CURRICULUM VITAE 5. NAME AND ADDRESS OF THE INSTITUTIONAL REVIEW BOARD (IRB) THAT IS RESPONSIBLE FOR REVIEW AND APPROVAL OF THE STUDY(IES). 4. NAME AND ADDRESS OF ANY CLINICAL LABORATORY FACILITIES TO BE USED IN THE STUDY. OTHER STATEMENT OF QUALIFICATIONS 7. NAME AND CODE NUMBER, IF ANY, OF THE PROTOCOL(S) IN THE IND FOR THE STUDY(IES) TO BE CONDUCTED BY THE INVESTIGATOR. (TITLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART 312) (See instructions on reverse side.) DEPARTMENT OF HEALTH AND HUMAN SERVICES PSC Graphics: (301) 443-1090EF |
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| Following Datasheets | UCM076724_1 (2 pages) UCM076727_1 (2 pages) UCM076778_1 (1 pages) UCM076848_1 (4 pages) UCM076880_1 (1 pages) UCM079504 (2 pages) UCM079936_1 (21 pages) UCM080534 (14 pages) UCM080778_1 (2 pages) UCM080788_1 (4 pages) |
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