M11（ステップ4）
- 電子的に構造化・調和された臨床試験実施計画書（CeSHarP）
- （原文）Clinical electronic Structured Harmonised Protocol (CeSHarP) [75.61KB]
- （原文）M11 Technical Specification [2.55MB]
- （原文）M11 Template [441.23KB]
ステップの説明はこちら
トレーニングマテリアル
M11
- 「電子的に構造化・調和された臨床試験実施計画書（CeSHarP）」に関するトレーニングマテリアル
- M11 Training Meterial Module 1: Overall Introduction to ICH M11 Deliverables and Training Overview
- M11 Training Meterial Module 2: Template Conventions Used in the ICH M11 Template
- M11 Training Meterial Module 3: Protocol Amendments
- M11 Training Meterial Module 4: Assessment of Risks and Benefits
- M11 Training Meterial Module 5: Trial Objectives and Associated Estimands
- M11 Training Meterial Module 6: Trial Schema, Schedule of Activities, Trial Design, Trial Population, Discontinuation and Withdrawal
- M11 Training Meterial Module 7: Trial Intervention and Concomitant Therapy
- M11 Training Meterial Module 8: Adverse Events, Serious Adverse Events, Product Complaints, Pregnancy and Post-partum Information, and Special Safety Situations
- M11 Training Meterial Module 9: Trial Oversight and Other Considerations
- M11 Training Meterial Module 10: ICH M11 Controlled Terminology