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FDA临床研究指南Oversight of Clinical Investi.pdf

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FDA临床研究指南Oversight of Clinical Investi

Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to . All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Ann Meeker O’Connell at 301-796- 3150, (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301- 827-1800, or (CDRH) Chrissy Cochran at 301-796-5490. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) August 2011 Procedural Monitoring-Guidance.doc 8/24/2011 Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Additional copies are available from: Office of Communications Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug