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Guidance for Industry Oversight of Clinical Investigations ¡ª A Risk-Based Approach to Monitoring ÐÐÒµÖ¸ÄÏ ÁÙ´²Ñо¿¼à¶½¡ª¡ªÒ»ÖÖ»ùÓÚ·çÏÕ½øÐÐÁÙ´²¼à²ìµÄ²ßÂÔ DRAFT GUIDANCE Ö¸Äϲݰ¸ This guidance document is being distributed for comment purposes only. ±¾Ö¸ÄÏÎļþ½öÓÃÓÚÕ÷ÇóÉç»áÒâ¼ûÓà 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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. ¹ØÓÚ±¾Ö¸Äϲݰ¸µÄÆÀÂۺͽ¨ÒéÇëÔÚ±¾Ö¸ÄϵÇÓÚÁª°î¹«±¨ºó90ÈÕÄÚÌá½»ÖÁÃÀ¹úʳƷҩƷ¹ÜÀí¾Ö¾í×Ú¹ÜÀí´¦£¨HFA-305£©£¬µØÖ·£º5630 Fishers Lane, rm. 1061, Rockville, MD 20852¡£µç×Ó·½Ê½µÄÆÀÂÛÇëÔÚhttp://www.regulations.govÍøÕ¾Ìá½»¡£ËùÓÐÆÀÂÛ¶¼ÒÔµÇÓÚÁª°î¹«±¨ÉϵĿÉÓÃÉùÃ÷¾í×ÚºÅ×÷Ϊʶ±ð±ê¼Ç¡£ 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. Èç¶Ô±¾Ö¸Äϲݰ¸ÓÐÒÉÎÊ£¬ÇëÁªÏµÒ©Æ·ÆÀ¼ÛºÍÑо¿ÖÐÐÄ£¨CDER£©Edwin Melendez£¬µç»°£º301-796-3284£» CDER¶ÔÍâÐÅÏ¢¡¢ÍâÁªÓë·¢Õ¹°ì¹«ÊÒ£¬µç»°£º 800-835-4709 »ò 301-827-1800£»»òÒ½ÁÆÆ÷еºÍ·øÉ佡¿µÖÐÐÄ£¨CDRH£©Chrissy Cochran£¬µç»°£º301-796-5490¡£ U.S. Department of Health and Human Services ÃÀ¹úÎÀÉúÓ빫ÖÚ·þÎñ²¿ Food and Drug Administration ÃÀ¹úʳƷҩƷ¹ÜÀí¾Ö Center for Drug Evaluation and Research (CDER) Ò©Æ·ÆÀ¼ÛºÍÑо¿ÖÐÐÄ(CDER) Center for Biologics Evaluation and Research (CBER) ÉúÎïÖÆÆ·ÆÀ¼ÛºÍÑо¿ÖÐÐÄ£¨CBER£© Center for Devices and Radiological Health (CDRH) Ò½ÁÆÆ÷еºÍ·øÉ佡¿µÖÐÐÄ£¨CDRH£© August 2011 2011Äê8Ô Procedural ³ÌÐòÐÔÖ¸ÄÏ TABLE OF CONTENTS Ŀ¼ I. INTRODUCTION...............................................................1 ¼ò½é II. BACKGROUND................................................................1 ±³¾° A. Current Monitoring Practices..............................................3 ĿǰµÄÁÙ´²¼à²ìʵ¼ù B. Other FDA Guidance on Monitoring...................................4 FDA·¢²¼µÄÆäËüÓйØÁÙ´²¼à²ìµÄÖ¸ÄÏÎļþ C. Rationale for Facilitating Risk-Based Monitoring¡¡ ...4 ´Ù½ø»ùÓÚ·çÏÕ»ù´¡µÄÁÙ´²¼à²ìµÄÀíÓÉ D. Steps FDA is Taking to Facilitate Wider Use of Alternative Monitoring Approaches..5 FDAĿǰ²ÉÈ¡µÄ´Ù½øÌæ´ú¼à²ì·½·¨¸ü¶àʹÓõĴëÊ© III. FACTORS THAT INFLUENCE STUDY QUALITY AND INTEGRITY.................6 Ó°ÏìÁÙ´²ÊÔÑéÖÊÁ¿ºÍÍêÕûÐÔµÄÒòËØ IV. GENERAL MONITORING RECOMMENDATIONS................................................7 ÓйØÁÙ´²¼à²ìµÄÒ»°ã½¨Òé A. Types of Monitoring........................................................................................................7 ÁÙ´²¼à²ìÀàÐÍ 1. On-Site Monitoring..........................................................................................................................7 ÏÖ³¡¼à²ì 2. Centralized Monitoring....................................................................................................................7 ¼¯Öмà²ì B. Identify Critical Data and Processes to be Monitored................................................................9 Ðè½øÐмà²ìµÄ¹Ø¼üÊý¾ÝºÍ³ÌÐòµÄÈ·¶¨ C. Factors to Consider when Developing a Monitoring Plan...........................................10 ¼à²ì¼Æ»®½¨Á¢Ê±Ó¦¿¼ÂǵÄÒòËØ D. Monitoring Plan...........................................................................................................................11 ÁÙ´²ÊÔÑé¼à²ì¼Æ»® 1. Description of Monitoring Approaches.........................................................................................11 ¼à²ì·½·¨µÄÃèÊö 2. Communication of Monitoring Results..........................................................................................12 ¹ØÓÚ¼à²ì½á¹ûµÄ¹µÍ¨ 3. Management of Noncompliance....................................................................................................12 ·ÇÒÀ´ÓÐÐΪµÄ¹ÜÀí 4. Training and Study-Specific Information.......................................................................................13 Åàѵ¼°ÊÔÑéÌØ¶¨ÐÅÏ¢ 5. Monitoring Plan Amendments.......................................................................................................13 ¼à²ì¼Æ»®ÐÞÕý V. DOCUMENTING MONITORING ACTIVITIES......................................................14 ¼à²ì»î¶¯¼Ç¼ VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY............................14 ±£Ö¤ÊÔÑéÖÊÁ¿µÄÆäËü²ßÂÔ A. Clinical Investigator Training and Communication.................................................................14 ÁÙ´²Ñо¿ÕßÅàѵÓë½»Á÷ B. Delegation of Monitoring Responsibilities to a CRO................................................................15 ½«¼à²ìÔðÈÎίÍиøCRO¹«Ë¾[ Last edited by lwjxz on 2011-9-24 at 15:26 ] |
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