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SOCRA Prep
Week 1 SOCRA Mindset
Week 1 Homework
Week 1 Overview
Week 1 Remediation
Week 1 Student Workbook & Templates
Week 2 Informed Consent
Reference
21 CFR Part 50 Info
Week 2 Homework
Week 2 In-Class Activities
Week 2 Overview
Week 2 Visual Aids
Week 3 IRB
Week 3 Homework
Week 3 Overview
Week 3 Remediation
Week 3 Targeted Understanding
Week 3 Visual Aids
Week 4 IDE IND
Gemini Interactives
Week 4 IND IDE Visuals
Reference
21 CFR Part 312 and 812
Week 4 IND and IDE Regulations and Responsibilities
Week 4 Overview
Week 4 Remediation
Week 5 ICH GCP E6 R3
Reference
ICH E6 R2 to R3 Transition Study Guide
ICH E6 R3 Visual Aids
ICH E6(R3) Transition
Week 5 Overview
Week 6 Data and Monitoring
Week 6 Overview
Week 7 AEs
Gemini Interactives
Week 7 Adverse Event Reporting and Safety Management
Visuals
Week 7 Visuals
Week 7 Learning Materials
Week 7 Overview
Week 7 Study Guide
Week 8 Protocol Development and Study Design
Week 8 Learning Packet
Week 8 Overview - Protocol Dev and Study Design
Week 8 Study Guide
Week 8 Visuals
Home
SOCRA Preparation
Course Home:
SOCRA Preparation
For this week:
PowerPoint
In Class Activities
Alt In Class
Practice Quiz
Week 5 quiz
Notes from Office Hours
ICH E6 R2 to R3 Transition Study Guide
Visual Aids
Homework
Resources
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