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Clinical Research Study Files 00:00:00 *** START VIDEO 00:00:10 Clinical Research Study Files 00:00:20 ACCME Requirement: CMEs 00:00:43 ANCCCA Requirement: CEUs 00:00:44 Purpose of Module 00:00:45 Module Outline 00:02:55 Essential Documents (ICH GCP Chapter 8) 00:03:22 Levels of Documents 00:03:33 *** STOP VIDEO 00:05:50 *** START VIDEO 00:07:16 Levels of Documents 00:07:26 Industry Sponsor Files 00:11:14 Investigator/Institution Files 00:11:35 The Clinical Research (CR) Study Files Binder 00:12:23 A Binder Prototype (compliments of CACR) 00:12:39 Title Page (instructions) 00:14:06 Document Sources 00:15:05 Index (Tab Inserts) 00:15:44 9. Laboratory Information [Tab] 00:16:07 Contents List [Index>>Tabs] 00:17:38 Final Advice on File Maintenance 00:18:04 File Organization Tips 00:18:19 File Organization Tips 00:19:07 File Design Tips 00:22:00 File Design Tips 00:22:49 Records Retention 00:23:43 Records Retention 00:26:07 Important Reminders 00:27:57 Keep files organized at all times 00:28:47 Ultimate Goal 00:28:50 End of Module 00:29:16 *** STOP VIDEO 00:29:20 00:29:26 Feedback and Certificates 00:29:29
