PART 1: CRITICAL SUCCESS FACTORS

#1: Master Timeline Calculations

Why: 30-40% of questions on SOCRA exam involve timeline calculations How: Daily drills throughout week Minimum: 20 scenarios calculated correctly Red Flag: If you struggle with calendar date math, use online calendar or excel

#2: Lock in Serious vs. Severe Distinction

Why: SOCRA's favorite trick question How: Flashcards + scenarios Minimum: Answer 10 scenarios correctly without hesitation Red Flag: If you say "mild event" = "serious," you're confused

#3: Apply the Decision Tree

Why: Systematically classify every scenario How: Use the same framework for every question Minimum: Can complete decision tree in <2 minutes per scenario Red Flag: If you're guessing instead of systematically going through criteria

#4: Know the Three Criteria for Expedited Reporting

Why: Core regulatory requirement How: Flashcards, scenarios, decision tree Minimum: Recite from memory: Serious + Unexpected + Suspected AR Red Flag: If you forget "unexpected" is required for expected events

#5: Understand Causality Threshold

Why: Low threshold ("Possible") trips up candidates How: Study five assessment factors, apply to scenarios Minimum: Know that "Possible" triggers AR Red Flag: If you wait for "Probable" causality, you're wrong

PART 2: HOMEWORK PACKET

Required Reading

1. 21 CFR 312.32 (Sponsor IND Safety Reporting)
   • Full regulatory text
   • Focus: Sections (c), (d), (e)
   • Time: 45 minutes
2. 21 CFR 312.64 (Investigator Reporting Obligations)
   • Focus: Investigator timelines (24 hours to sponsor, 24hrs-5days to IRB)
   • Time: 20 minutes
3. ICH E2A (Clinical Safety Data Management)
   • Focus: Terminology definitions
   • Available: Online at ICH website
   • Time: 45 minutes (skim for definitions; detail reading 1.5 hours)
4. ICH E6(R3) (Good Clinical Practice)
   • Sections: 4.8 (Safety), 5.8 (Safety data monitoring)
   • Time: 30 minutes

Practice Assignments

Assignment 1: Timeline Calculation Worksheets (50 scenarios)

• Across 5 days (10 per day)
• Solutions provided for self-check
• Target: 95%+ accuracy
• Time: 25 minutes per day

Assignment 2: Weekly Quiz #6

• 50 questions, 75 minutes
• Untimed: Review/study
• Timed: Full exam simulation Friday evening
• Retake if needed: Saturday morning
• Target: 75% minimum, 85%+ ideal

Assignment 3: Practice Question Bank (50 questions)

• Study Guide Sections 1-4
• Available: All answers with step-by-step explanations
• Complete: At least 40 of 50 questions
• Target: 80%+ accuracy

Assignment 4: Flashcard Mastery

• Daily: 15 minutes with flashcard set
• Target: Know 95% by Friday
• Method: Active recall (cover answers)

Assignment 5: Decision Tree Creation Exercise

• Create your own visual decision tree for "What type of report is required?"
• Include: All decision points, criteria, timelines
• Purpose: Demonstrates understanding
• Bring: To office hours for feedback

Assignment 6: 20 Timeline Calculation Drills with Step-by-Step Solutions

• Provided: In Timeline Calculation Tool
• Complete: All 20
• Time: 30 minutes total (1.5 min per scenario)
• Target: 100% accuracy

PART 3: RESOURCES PROVIDED

Study Materials

• 50-slide presentation with speaker notes
• 50-question quiz with answer key
• 70-card flashcard set
• Timeline calculation tool (20+ scenarios)
• 50-question practice bank
• Comprehensive study guide with content sections
• Quick reference card
• Adverse event safety management report
• Practice questions with explanations (from uploads)

Tools

• Online flashcard platform (create account: Quizlet, Anki, or similar)
• Calendar app (for timeline calculation practice)
• Excel spreadsheet (for tracking your practice scores)

External Resources

• 21 CFR Part 312: https://www.ecfr.gov/current/title-21/part-312
• ICH Guidelines: https://www.ich.org
• FDA Guidance Documents: https://www.fda.gov/guidance

PART 4: OFFICE HOURS PREPARATION

Bring to Office Hours:

1. Quiz #6 Results
   • Your score
   • Questions missed (with your answers)
   • Areas of confusion
2. Timeline Calculation Practice
   • Any scenarios you got wrong
   • Specific date calculations that trip you up
   • Calendar counting challenges
3. Serious vs. Severe Examples
   • Scenarios where you're uncertain
   • Real exam questions you found confusing
   • Clinical situations that blur the line
4. Decision Tree Exercise
   • Your created decision tree
   • Any sections you're unsure about
   • Edge cases or complex scenarios
5. Study Strategy Questions
   • What's working well?
   • Where are you struggling?
   • How much time are you committing?
   • Are you ready for exam timing?

Common Office Hours Topics:

• Timeline calculations: "When does the 7-day clock start?"
• Serious vs. Severe: "Is hospitalization always serious?"
• Causality: "What counts as 'reasonable possibility'?"
• Expectedness: "Which IB version do I use?"
• Edge cases: "What if both SAE and SAR apply?"
• Efficiency: "How can I answer faster on the exam?"

Office Hours Agenda (30-45 minutes):

1. Quick Check-In (5 min): How's the week going?
2. Quiz Review (10 min): Top 3 problem areas
3. Deep Dive (15-20 min): Focus on your weak area
4. Strategy Adjustment (5-10 min): Any study changes needed?
5. Next Week Preview (5 min): Protocol development coming up

PART 5: WEEK 8 PREVIEW

Next Week's Topic: PROTOCOL DEVELOPMENT AND MANAGEMENT

Connection to Week 7:

• Week 7 safety management → Week 8 protocol safety sections
• Week 7 investigator obligations → Week 8 protocol investigator requirements
• Week 7 SAE criteria → Week 8 safety monitoring plans

Pre-Work for Week 8:

1. Review protocol template (if provided)
2. Understand basic protocol structure (objectives, endpoints, safety monitoring)
3. Familiarize with protocol sections
4. Bring questions about safety sections from Week 7

Why This Matters: Protocol development accounts for ~12% of SOCRA exam. Understanding safety requirements from Week 7 makes Week 8 much easier.

PART 6: STUDY TIPS FROM SOCRA EXAM SURVIVORS

Time Management

• Don't perfectionism: 85% mastery → move on
• Prioritize high-yield content: Timelines > philosophy
• Batch similar content: All timelines together, not scattered
• Daily review: 10 minutes flashcards every day > 60-min cram

Avoiding Common Pitfalls

1. Timeline calculations: Remember Day 0 = sponsor awareness, not event date
2. Calendar vs. business days: Always calendar days
3. Expected events: Even serious + causality doesn't mean expedited if expected
4. Causality threshold: "Possible" is enough; don't wait for "Probable"
5. Serious vs. severe: These are independent; don't conflate them

PART 7: SELF-ASSESSMENT RUBRIC

Rate Yourself (1-5 scale, 5 = expert):

Understanding of Concepts:

• AE, AR, SAE, SAR definitions: ___/5
• Six SAE criteria: ___/5
• Serious vs. Severe distinction: ___/5
• Causality assessment: ___/5
• Expectedness determination: ___/5

Application Skills:

• Classify events into categories: ___/5
• Calculate timelines correctly: ___/5
• Apply decision tree: ___/5
• Assess causality from scenarios: ___/5
• Determine expectedness: ___/5

Regulatory Knowledge:

• 21 CFR 312.32 requirements: ___/5
• 21 CFR 312.64 obligations: ___/5
• ICH E2A definitions: ___/5
• Three-criteria rule for expedited: ___/5

Exam Readiness:

• Overall confidence: ___/5
• Time management: ___/5
• Ability to think under pressure: ___/5
• Readiness for exam day: ___/5

Goal: All items at 4-5 by end of week

FINAL WORDS

This week's content is foundational. Adverse event reporting touches nearly every aspect of clinical research. Mastery here:

✓ Helps you understand investigator roles (Week 8+)
✓ Informs protocol development decisions (Week 8)
✓ Supports informed consent content (Week 10)
✓ Connects to IRB review (Week 11)
✓ Underlies safety monitoring (throughout course)

Questions? Refer back to:

• Presentation slides for overview
• Study guide for detailed content
• Flashcards for quick review
• Timeline tool for calculation practice
• Quiz explanations for concept clarification

Good luck on Week 7!