FDA规则：临床信息的收集传输和管理演示幻灯片.pptVIP

* Compliance with FDA Regulations:Collecting, Transmitting and Managing Clinical Information Dan C Pettus Senior Vice President iMetrikus, Inc. What does Regulation Mean? For devices, drugs, etc., it means the manufacturer is held accountable for GMP and QSR under Title 21 parts 1 to 1299 (e.g., part 801- Labeling, part 820 – Quality System) Ability to electronically authenticate is permitted under 21 part 11 of the FDA regulations The FDA issued guidance documents which identify portions of title 21 part 11 as being applicable for clinical trials submissions NOTE: Clinical Information may