00:00:10
slide 002
JUMP DIRECTLY TO SLIDE
Clinical Research Study Files
*** START VIDEO
Clinical Research Study Files
ACCME Requirement: CMEs
ANCCCA Requirement: CEUs
Purpose of Module
Module Outline
Essential Documents (ICH GCP Chapter 8)
Levels of Documents
*** STOP VIDEO
*** START VIDEO
Levels of Documents
Industry Sponsor Files
Investigator/Institution Files
The Clinical Research (CR) Study Files Binder
A Binder Prototype (compliments of CACR)
Title Page (instructions)
Document Sources
Index (Tab Inserts)
9. Laboratory Information [Tab]
Contents List [Index>>Tabs]
Final Advice on File Maintenance
File Organization Tips
File Organization Tips
File Design Tips
File Design Tips
Records Retention
Records Retention
Important Reminders
Keep files organized at all times
Ultimate Goal
End of Module
*** STOP VIDEO
Feedback and Certificates
synchronize video with current slide
