20110117 MHLW 新医薬品の総審査期間短縮に向けた申請に係るCTDのフォーマットについて

医薬食品局 新着の通知

平成２３年１月１９日掲載


* 新医薬品の総審査期間短縮に向けた申請に係るCTDのフォーマットについて（平成23年１月17日　事務連絡）(PDF,236KB)【医薬食品局審査管理課　薬事法関係】

http://wwwhourei.mhlw.go.jp/hourei/doc/tsuchi/T110119I0010.pdf

20110106 FDA draft guidance "Electronic Source Documentation in Clinical Investigations"

Electronic Source Documentation in Clinical Investigations
DRAFT GUIDANCE

TABLE OF CONTENTS
I. INTRODUCTION
II. BACKGROUND
III. ELECTRONIC SOURCE DOCUMENTS AND SOURCE DATA
A. Tier 1 - Data Entry
1. Data Elements
2. Data Element Attributes and Data Element Identifiers
3. Modifications and Corrections
4. Repeated Appearance of the Same Data Element in an eCRF
5. Electronic Prompts to Ensure Accuracy and Completeness of Data
6. Originators of Data Elements
7. Identification of Data Originators
B. Tier 2 – Data Review
1. The Investigator
2. The Investigator’s Copy of the eCRF
C. Tier 3 -- Data Processing and Transmission
IV. REGULATORY REVIEW COLLABORATION
GLOSSARY OF TERMS

20110112 European Medicines Agency opens public discussion on need for active control in clinical trials

reflection paper
http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500100710&murl=menus/news_and_events/news_and_events.jsp&mid=0b01ac058009a3dc