WEEK 8 STUDY GUIDE

Protocol Development and Study Management

SOCRA CCRP Exam Preparation - Integrated Learning Path

QUICK START GUIDE FOR THE WEEK

If You Have LIMITED TIME (4 hours)

1. Review PowerPoint slides (45 minutes)
2. Study Flashcards (30 minutes)
3. Complete Deviation Classification Activity (45 minutes)
4. Take Quick Quiz (20 questions, 30 minutes)
5. Practice Drug Accountability Calculations (60 minutes)

If You Have MODERATE TIME (8 hours)

1. Attend live class (2 hours)
2. Review slides & comprehensive packet (2 hours)
3. Complete homework activities (2 hours)
4. Study flashcards (1 hour)
5. Complete 45-question quiz (1.5 hours)

If You Have FULL TIME (10+ hours)

1. Attend live class (2 hours)
2. Read comprehensive packet thoroughly (3 hours)
3. Study flashcards systematically (1.5 hours)
4. Complete all homework activities (2 hours)
5. Take 45-question quiz (1.5 hours)
6. Drill practice question bank (additional 2-3 hours)

WHAT GETS TESTED: EXAM FREQUENCY ANALYSIS

Based on SOCRA exam outline and historical patterns:

HIGH FREQUENCY (Tested Multiple Times)

• Deviation vs. Violation distinction (~20+ questions on exam)
• Protocol required elements (~12-15 questions)
• Inclusion/Exclusion criteria application (~8-10 questions)
• Drug accountability calculations (~10-12 questions)
• Amendment vs. Administrative change (~7-8 questions)

MODERATE FREQUENCY (Tested Once or Twice)

• IRT/IWRS system functions (~4-5 questions)
• Enrollment of ineligible subjects (~3-4 questions)
• Protocol amendments process (~3-4 questions)

LOWER FREQUENCY (Tested Occasionally)

• Protocol document structure vs. referenced documents (~2-3 questions)
• Design types (parallel, crossover, factorial) (~2-3 questions)

LEARNING OBJECTIVES CHECKLIST

Before moving to next week, verify you can:

Protocol Structure (16 Sections)

• Name all 16 sections of ICH E6 Section 6
• Explain what belongs in each section
• Distinguish Section 6.1 from 6.9
• Know which sections address safety (6.8 vs. 6.12)

Eligibility & Screening

• Define screening failure with example
• Explain why eligibility assessed at enrollment, not screening
• Calculate washout period (5 × half-life)
• Know requirement for ineligible subject enrollment (Sponsor + IRB)

Amendments & Changes

• Distinguish amendment from administrative change
• List 5 changes requiring amendment
• Describe implementation timeline (FDA receipt + IRB approval)
• Know new investigator notification timeline (30 days)

Deviations vs. Violations

• Define deviation, major deviation, violation
• Explain why NOT all deviations are violations
• Know 6-step management process
• Understand CAPA (corrective & preventive)
• Know reporting timelines (sponsor, IRB, FDA)

IRT/IWRS Systems

• Describe randomization automation advantage
• Know when emergency unblinding is appropriate
• Understand blinding maintenance mechanisms
• List core IRT functions (7 main ones)

Drug Accountability

• Recite master equation (Received = Dispensed + Destroyed + Remaining)
• Solve 3 types of calculations (missing received, dispensed, remaining)
• Describe temperature excursion response
• Know investigator's non-delegable responsibility
• Cite regulations (21 CFR 312.57, .58, .61)

COMMON TROUBLE AREAS FOR STUDENTS

Area 1: Deviation vs. Violation Distinction

Why students struggle: Both involve protocol non-adherence, but consequences very different Solution: Remember: Violation = SIGNIFICANT impact on safety/data/compliance Practice: Do all 10 deviation/violation classification questions in practice bank

Area 2: Drug Accountability Calculations

Why students struggle: Easy to confuse "Returned" with separate category Solution: Remember: Returned is SUBSET of Dispensed (not separate) Formula: Received = Dispensed + Destroyed + Remaining (Returned is part of Dispensed) Practice: Complete all 10 calculation worksheets

Area 3: Eligibility Assessment Timing

Why students struggle: Assume if met at screening, can enroll Solution: Remember: Assessment at ENROLLMENT, not screening Critical Rule: All criteria must be met at TIME OF RANDOMIZATION Example: Subject ages out between screening and enrollment → CANNOT enroll without waiver

Area 4: Amendment Implementation

Why students struggle: Think sponsor OR IRB approval sufficient Solution: Need BOTH conditions:

1. FDA received amendment
2. IRB approved amendment Then: Can implement while FDA reviews

Area 5: Protocol Structure (Where Things Go)

Why students struggle: Many sections, hard to remember which goes where Solution: Study 3 "anchor" sections: 6.1 (admin), 6.4 (design), 6.9 (stats) Then: Learn where other sections fit relative to these anchors

STUDY STRATEGY BY LEARNING STYLE

Visual Learners

Use These Resources:

• Flowcharts (Amendment vs. Administrative Change decision matrix)
• Diagrams (Deviation Classification Guide)
• Visual worksheets (Accountability calculations with step-by-step)
• Infographics (IRT System Workflow)
• Color-coded flashcards

Auditory Learners

Use These Resources:

• Attend live class (45 minutes)
• Office hours (ask questions, discuss)
• Read flashcards aloud
• Teach a concept to study partner
• Listen to yourself explain deviations vs. violations

Reading/Writing Learners

Use These Resources:

• Read comprehensive packet thoroughly
• Write out protocol sections from memory
• Create your own case study scenarios
• Write detailed answers to practice questions
• Summarize each section in your own words

Kinesthetic Learners

Use These Resources:

• Complete interactive activities (scavenger hunt, games)
• Work through drug accountability calculations step-by-step
• Do case studies with hands-on classification
• Create physical flashcards
• Build your own protocol outline

DAILY STUDY SCHEDULE RECOMMENDATION

Monday (Class Day)

• 9:00-10:45: Attend live class
• 11:00-12:00: Review slides (section by section)
• 13:00-14:00: Read Sections 1-3 of comprehensive packet

Tuesday

• 9:00-10:00: Study flashcards (all 60 cards, mix up order)
• 10:00-11:00: Re-read challenging section from packet
• 13:00-14:00: Complete one interactive activity (scavenger hunt or eligibility exercise)

Wednesday

• 9:00-11:00: Complete drug accountability worksheet (all 5 problems)
• 13:00-14:00: Study flashcards again (focus on problem cards)
• 14:00-15:00: Complete case studies (classify 5 deviation scenarios)

Thursday

• 9:00-10:00: Review flashcards one more time
• 10:00-11:00: Re-read sections you're weakest on
• 13:00-15:00: Complete 45-question quiz (timed: 70 minutes)
• 15:00-17:00: Review quiz answers, note weak areas

Friday

• 9:00-12:00: Drill weak areas with practice question bank
• 13:00-14:00: Final flashcard review
• 14:00-15:00: Re-do 3 practice calculations
• 15:00-17:00: Study Week 9 preview material

Weekend

• Saturday: Review all case studies
• Sunday: Final comprehensive review, rest before next week

HOW TO USE EACH MATERIAL TYPE

PowerPoint Slides (45 minutes)

How to use:

1. Listen to lecture on Week 8 live class
2. Review slides for 1 hour independently
3. Use as reference during homework
4. Return to specific slides when weak area identified

Best for: Overview + structure of content

Comprehensive Packet (3-4 hours)

How to use:

1. Read Section 1 (learning objectives) to set expectations
2. Read Sections 2-7 in detail (take notes)
3. Return to specific sections for clarification
4. Reference when completing assignments

Best for: Deep understanding of all concepts

Interactive Activities (40 minutes total)

How to use:

1. Scavenger Hunt: Identify missing protocol sections
2. Eligibility Game: Determine if subjects meet criteria
3. Deviation Classification: Rapidly classify scenarios
4. Drug Accountability: Complete calculations

Best for: Active learning, confidence building

Weekly Quiz (70 minutes)

How to use:

1. Take it TIMED (70 minutes = 1.5 min per question)
2. Don't look at answers while taking
3. After completing, review answer key thoroughly
4. Identify patterns in wrong answers
5. Drill weak areas with practice bank

Best for: Self-assessment, exam preparation

Practice Question Bank (45 additional questions)

How to use:

1. After taking main quiz, drill weak areas
2. Use subset of questions by topic (e.g., just deviations)
3. Aim for 80%+ accuracy
4. Review explanations, not just answers

Best for: Targeted remediation

Flashcards (60 cards)

How to use:

1. Day 1-2: Full review of all 60 cards
2. Day 3-5: Focus on difficult cards (repeated review)
3. Day 6-7: Final comprehensive review
4. Mix up order each time (don't learn sequence)
5. Teach another person using the cards

Best for: Retention, quick review, terminology

Drug Accountability Worksheet (90 minutes)

How to use:

1. Complete all 5 practice sets with solutions
2. Blank worksheets: Practice without solutions
3. Create your own problems and solve them
4. Master the formula until automatic recall

Best for: Calculation mastery, confidence

Case Study Handouts (120 minutes)

How to use:

1. Scenario 1-5: Classify deviations, provide reasoning
2. Scenario 2.1-2.5: Complete drug accountability reconciliations
3. Discuss in study groups
4. Use for office hours review

Best for: Real-world application, exam simulation

RED FLAGS: WHEN YOU NEED EXTRA HELP

If You're Struggling With...

Deviation Classification:

• → Re-read Section 5 of comprehensive packet
• → Complete all 10 quiz deviation questions again
• → Drill Case Study 1 scenarios
• → Office hours: Ask about gray areas

Drug Accountability:

• → Work through all 5 calculation worksheets twice
• → Create your own 3 test problems
• → Practice mental math (quick calculation)
• → Office hours: Walk through one complex scenario

Protocol Elements:

• → Create flashcards with visual associations
• → List 16 sections and sub-topic by memory
• → Create your own protocol outline
• → Office hours: How to keep them straight

Amendment vs. Administrative:

• → Create decision matrix on poster board
• → Make visual flowchart
• → Quiz yourself on 10 examples
• → Office hours: Edge cases that confuse you

WEEK 8 VOCABULARY MASTERY

MUST KNOW (define from memory):

• Protocol Deviation
• Protocol Violation
• Screening Failure
• Inclusion Criteria
• Exclusion Criteria
• Protocol Amendment
• Administrative Change
• Corrective Action
• Preventive Action
• Chain of Custody
• IRT / IWRS
• Blinding
• Drug Accountability

MUST UNDERSTAND (explain, not just define):

• Why enrollment of ineligible subjects is major violation
• Why amendments need FDA + IRB approval
• Why deviations ≠ violations
• Why IRT preferred over manual randomization
• Why drug accountability regulations exist

MUST APPLY (use in scenarios):

• Classify real deviations as minor/major/violation
• Solve drug accountability calculations
• Determine if change requires amendment
• Develop CAPA plan
• Plan deviation investigation

EXAM DAY PREPARATION

The Week Before (Day 1-6)

• Complete all materials
• Drill weak areas
• Use office hours strategically
• Get good sleep Thu-Fri nights

Day Before Exam

• Review flashcards (quick pass)
• Look over drug accountability formula
• Review case studies
• DO NOT cram new material
• Get 8+ hours sleep

Exam Day

• Arrive early
• Review formula one more time before starting
• READ EVERY QUESTION CAREFULLY (deviation questions are tricky)
• Flag for review before submitting
• Don't overthink (first instinct often correct)

OFFICE HOURS STRATEGY

What to Bring

• Quiz showing your wrong answers
• Practice questions that confused you
• Real-world scenarios from your work
• Specific case study question

What to Ask

1. "Can you explain why [wrong answer] is incorrect?"
2. "How do I quickly classify deviations?"
3. "Walk me through this drug accountability problem"
4. "What am I missing about protocol structure?"

What NOT to Do

• Don't ask me to re-teach entire section
• Don't ask questions answered in materials
• Don't ask for answers without working through first

CONNECTING TO YOUR PRACTICE

For Clinical Research Coordinators

"As a coordinator, I'll use this when:

• Screening subjects (eligibility)
• Documenting deviations
• Managing drug inventory
• Reporting to sponsor"

For Research Managers

"As a manager, I'll use this when:

• Reviewing protocols
• Training staff
• Managing deviations
• Conducting audits
• Ensuring compliance"

For Data/Analytics Staff

"As a data professional, I'll use this when:

• Understanding inclusion/exclusion impact on analysis
• Reviewing deviation impact on data
• Building reports on drug accountability"

FINAL WEEK 8 MASTERY CHECKLIST

• Attended live class (45 min)
• Reviewed all slides (1 hour)
• Read comprehensive packet (3 hours)
• Completed scavenger hunt activity (10 min)
• Completed eligibility practice (12 min)
• Completed deviation classification game (10 min)
• Completed drug accountability activity (8 min)
• Studied flashcards systematically (1.5 hours)
• Completed drug accountability worksheet (1.5 hours)
• Completed case studies (2 hours)
• Took 45-question quiz timed (1.5 hours)
• Reviewed quiz answers thoroughly (1 hour)
• Completed at least 20 questions from practice bank (additional 1 hour)
• Attended office hours if struggled (20-30 min)

Total Time Investment: 10-12 hours

Expected Outcome: 75%+ on quiz, 80%+ on practice bank

NEXT WEEK PREVIEW: WEEK 9

Topic: Subject Management and Study Conduct

Key Content:

• Recruitment and enrollment procedures
• Subject informed consent process
• Ongoing monitoring and compliance
• Subject withdrawal and follow-up
• Study closeout procedures

Connection to Week 8:

• Use eligibility criteria you developed to screen Week 9 subjects
• Apply protocol amendments knowledge to protocol changes during study
• Use deviation classification skills for Week 9 conduct deviations

FINAL MOTIVATION

You've got this!

Week 8 content is heavily tested because it's CRITICAL:

• Enrollment of ineligible subjects has shut down trials
• Protocol deviations are most commonly cited in FDA Warning Letters
• Drug accountability is foundational to regulatory acceptance

By mastering Week 8, you're building the knowledge that separates excellent clinical research professionals from adequate ones.

You now understand: ✓ How to design protocols that protect subjects ✓ How to identify and manage protocol problems ✓ How to maintain drug accountability ✓ How to ensure regulatory compliance

These skills will serve you well throughout your career.

END OF STUDY GUIDE

Good luck with Week 8! You've got comprehensive materials, clear learning objectives, and a proven path to success.

See you in office hours if you need clarification!