Week 1 Overview

Table of Contents

1. SOCRA CCRP Exam Preparation Course
2. 📋 OVERVIEW & LEARNING OBJECTIVES
3. ✅ ASSIGNMENT CHECKLIST
4. 📝 ASSIGNMENT 1: Baseline Knowledge Quiz
   1. Purpose
   2. Instructions
   3. What to Expect
   4. Time Commitment
   5. Tips for Success
   6. After the Quiz
5. 📖 ASSIGNMENT 2: Read & Annotate 21 CFR Part 50 (Informed Consent)
   1. Purpose
   2. Instructions
   3. What to Read (in order)
   4. Time Commitment
   5. ANNOTATION GUIDE
      1. For Each Section:
   6. SPECIFIC ANNOTATION PROMPTS BY SECTION
   7. CREATING YOUR SUMMARY NOTES
6. 🔍 ASSIGNMENT 3: Resource Scavenger Hunt
   1. Purpose
   2. Instructions
   3. Time Commitment
   4. SCAVENGER HUNT CHECKLIST
   5. SUBMISSION FORMAT
7. 📅 ASSIGNMENT 4: Create Your 12-Week Study Calendar
   1. Purpose
   2. Instructions
   3. Time Commitment
   4. STEP 1: Assess Your Weekly Schedule
   5. STEP 2: Block Out Fixed Commitments
   6. STEP 3: Schedule Study Time
   7. STEP 4: Color-Code Your Activities
   8. STEP 5: Weekly Review Ritual
   9. EXAMPLE WEEK (Monday-Sunday)
   10. SUBMISSION
8. 🎧 ASSIGNMENT 5: Listen to Dan Sfera Chapters 1-2
   1. Purpose
   2. Instructions
   3. Time Commitment
   4. LISTENING GUIDE
   5. CHAPTER 1 NOTES TEMPLATE
   6. CHAPTER 2 NOTES TEMPLATE
   7. SUBMISSION
9. 💭 ASSIGNMENT 6: Reflection Worksheet - "Applying SOCRA Mindset to My Work"
   1. Purpose
   2. Time Commitment
   3. PART 1: The Four Pillars in Your Work
   4. PART 2: Bridging Implementation Science and IND Research
   5. PART 3: Personal Learning Goals
   6. SUBMISSION
10. 📬 SUBMISSION INSTRUCTIONS
    1. How to Submit
    2. What to Submit
    3. Formatting Requirements
11. ❓ GETTING HELP
    1. If You're Stuck
12. 💪 MOTIVATION & ENCOURAGEMENT
    1. Week 1 Success Mantra
13. 📅 LOOKING AHEAD: Week 2 Preview

Week 1 → Week 2 Homework Assignment Packet

SOCRA CCRP Exam Preparation Course

Due Date: Next Week
Estimated Time: 6-7 hours total
Submission: Via course platform

📋 OVERVIEW & LEARNING OBJECTIVES

By completing this week's homework, you will:

• ✓ Establish your baseline knowledge through diagnostic assessment
• ✓ Master the fundamentals of informed consent (21 CFR Part 50)
• ✓ Develop familiarity with regulatory document navigation
• ✓ Create a personalized 12-week study system
• ✓ Begin building your regulatory knowledge foundation

Remember: Week 1 is about building systems and establishing habits. Quality over speed!

✅ ASSIGNMENT CHECKLIST

Use this checklist to track your progress:

• Assignment 1: Complete Baseline Knowledge Quiz (25 questions)
• Assignment 2: Read & Annotate 21 CFR Part 50
• Assignment 3: Resource Scavenger Hunt
• Assignment 4: Create Your 12-Week Study Calendar
• Assignment 5: Listen to Dan Sfera Chapters 1-2
• Assignment 6: Reflection Worksheet - "Applying SOCRA Mindset"

📝 ASSIGNMENT 1: Baseline Knowledge Quiz

Purpose

This diagnostic assessment identifies your current knowledge level and learning priorities. It's NOT graded—think of it as your "before" picture!

See Week 1 Overview for a link to the assessment quiz.

Tips for Success

• Find a quiet space without distractions
• Read each question carefully—watch for words like "FIRST," "MOST," "EXCEPT"
• If you don't know an answer, make your best guess (no penalty for wrong answers)
• Don't spend more than 2 minutes on any single question

After the Quiz

📊 Self-Reflection Questions:

1. Which domain felt most comfortable? Why?
2. Which domain felt most challenging? Why?
3. What surprised you about the quiz?
4. What specific topics do you need to prioritize?

_Note: Your quiz results will help you understand where to study

📖 ASSIGNMENT 2: Read & Annotate 21 CFR Part 50 (Informed Consent)

Purpose

21 CFR Part 50 is the foundation of informed consent in FDA-regulated research. This reading introduces you to federal consent requirements that will appear throughout the SOCRA exam.

Instructions

1. Download 21 CFR Part 50 from: [www.ecfr.gov → Title 21 → Part 50]
2. Read all sections with the annotation guide below
3. Use the annotation prompts to engage actively with the text
4. Create summary notes in your own words

What to Read (in order)

• ✓ Subpart A: General Provisions (§50.1 - §50.27)
• ✓ Subpart B: Informed Consent (§50.20 - §50.27)
• ✓ Pay special attention to: §50.25 (Elements of informed consent)

Time Commitment

⏱️ 2-3 hours (reading + annotations + notes)

ANNOTATION GUIDE

As you read, use these prompts to annotate (write in margins, use highlighters, or create notes):

For Each Section:

📌 HIGHLIGHT KEY DEFINITIONS

• Circle or highlight any bolded terms or definitions
• Example: "legally authorized representative," "minimal risk"

❓ ASK QUESTIONS

• Note anything confusing with a "?"
• Example: "What counts as 'undue influence'?"

🔗 MAKE CONNECTIONS

• Link to your own research experience
• Example: "This is why our consent forms have that language!"

⭐ MARK EXAM-LIKELY CONTENT

• Star anything that seems testable
• Example: The 8 basic elements of informed consent

📝 SUMMARIZE IN YOUR WORDS

• After each subpart, write a 1-sentence summary
• Example: "§50.25 = what must be in every consent form"

SPECIFIC ANNOTATION PROMPTS BY SECTION

§50.1 (Scope)

• What research does Part 50 apply to?
• Are there exemptions? What are they?

§50.3 (Definitions)

• How is "minimal risk" defined? Give an example from your work.
• What is a "legally authorized representative"?

§50.20 (General Requirements)

• What makes consent "legally effective"?
• What does "sufficient opportunity to consider" mean in practice?

§50.23 (Exception from general requirements)

• Under what circumstances can informed consent be waived?
• What must be documented if an exception applies?

§50.24 (Exception for emergency research)

• What are the criteria for emergency research exception?
• Have you ever worked on a study using this exception?

§50.25 (Elements of informed consent) ⭐ CRITICAL SECTION - Annotate thoroughly!

For BASIC ELEMENTS [§50.25(a)]: Create a numbered list of all 8 required elements. For each element:

1. Rewrite in your own words
2. Give an example of how this appears in actual consent forms
3. Think: Why is this element required? What does it protect?

Example annotation:

§50.25(a)(1) - Statement that research is involved
MY WORDS: Must tell participant this is research, not regular care
EXAMPLE: "You are being invited to participate in a research study..."
WHY: Distinguishes research from clinical care; manages expectations

For ADDITIONAL ELEMENTS [§50.25(b)]:

• Which of these have you seen in consent forms?
• Why would these be important to include?

§50.27 (Documentation of informed consent)

• When must consent be documented in writing?
• What are the requirements for the person obtaining consent?

CREATING YOUR SUMMARY NOTES

After reading, create a one-page summary addressing:

1. The Big Picture: What is 21 CFR Part 50 trying to accomplish?

2. The 8 Basic Elements: List them from memory (then check your accuracy)

3. Key Principles: What are the 3-5 most important takeaways?

4. Practical Application: How does this apply to your current/past research work?

5. Questions for Office Hours: What concepts need clarification?

🔍 ASSIGNMENT 3: Resource Scavenger Hunt

Purpose

Build confidence navigating FDA and ICH websites so you can find information quickly when needed. These navigation skills are valuable for both the exam and your career!

Instructions

Complete the scavenger hunt below. For each item, find the resource and record:

• ✓ The direct URL
• ✓ How you found it (navigation path)
• ✓ One interesting fact from the resource

Time Commitment

⏱️ 45-60 minutes

SCAVENGER HUNT CHECKLIST

TASK 1: Find 21 CFR Part 56 (IRB Regulations)

• Starting point: www.ecfr.gov
• Record the URL: _______________
• Navigation path: _______________
• Interesting fact: _______________

TASK 2: Find ICH E6(R2) Good Clinical Practice

• Starting point: www.fda.gov
• Record the URL: _______________
• Navigation path: _______________
• Interesting fact: _______________

TASK 3: Find 21 CFR Part 312 (INDs)

• Starting point: www.ecfr.gov
• What does IND stand for? _______________
• Record the URL: _______________
• Interesting fact about IND submission requirements: _______________

TASK 4: Find the OHRP (Office for Human Research Protections) Website

• Starting point: www.hhs.gov or Google
• Record the URL: _______________
• Find one useful resource on their site: _______________

TASK 5: Find FDA's "Guidance for Industry" Database

• Starting point: www.fda.gov
• Record the URL to the guidance database: _______________
• Find one guidance document related to informed consent: _______________

TASK 6: Find SOCRA's Website and Exam Information

• Starting point: www.socra.org
• Where is exam information located on the site? _______________
• What are the eligibility requirements for CCRP? _______________

TASK 7: Bookmark These for Easy Access

• Did you bookmark/favorite all the above resources? _______________
• Did you create a "SOCRA Prep" bookmark folder? _______________

SUBMISSION FORMAT

Create a document with:

1. All URLs found
2. Brief navigation notes for each
3. Your top 3 most useful discoveries
4. Screenshot of your organized bookmark folder (optional but recommended)

📅 ASSIGNMENT 4: Create Your 12-Week Study Calendar

Purpose

Successful certification requires consistent effort over 12 weeks. Creating your calendar NOW ensures you have a realistic, sustainable plan.

Instructions

Use the provided template (or create your own) to schedule:

• Live class times (45 min/week)
• Office hours (30 min/week)
• Daily/weekly study blocks
• Practice quiz times
• Review sessions
• Buffer time for catching up

Time Commitment

⏱️ 45-60 minutes

STEP 1: Assess Your Weekly Schedule

Work Schedule:

• Work days/hours: _______________
• Commute time: _______________
• Travel frequency: _______________

Personal Commitments:

• Family obligations: _______________
• Regular activities: _______________
• Other commitments: _______________

Available Study Time:

• Weekday mornings: _______________
• Weekday lunches: _______________
• Weekday evenings: _______________
• Weekend mornings: _______________
• Weekend afternoons: _______________
• Other pockets of time: _______________

STEP 2: Block Out Fixed Commitments

In your calendar, first block:

1. Live class sessions (Weeks 1-12)
2. Office hours (Weeks 1-12)
3. Personal commitments that can't move
4. Work schedule
5. Sleep (seriously—don't sacrifice sleep!)

STEP 3: Schedule Study Time

Weekly Study Target: 5-7 hours (not including live sessions)

Break it down:

• Reading/Regulations: 2-3 hours
• Audio (Dan Sfera): 1-2 hours
• Practice Questions: 1-2 hours
• Review/Notes: 1 hour

Scheduling Tips:

• ✓ Use "dead time" (commute, lunch, waiting) for audio learning
• ✓ Schedule focused reading when your brain is fresh
• ✓ Practice questions when you can write/type
• ✓ Review sessions in the evening or before bed
• ✓ Batch similar activities when possible
• ✓ Build in 1-2 hours of buffer time weekly

STEP 4: Color-Code Your Activities

Use colors to visualize your schedule:

• 🔴 Live Sessions (fixed)
• 🟢 Reading Time
• 🔵 Audio Learning
• 🟡 Practice Questions
• 🟣 Review/Notes
• ⚪ Buffer/Flex Time

STEP 5: Weekly Review Ritual

Schedule 30 minutes every Sunday evening (or your preferred day) for:

1. Review what you accomplished this week
2. Assess what needs more time next week
3. Preview upcoming week's assignments
4. Adjust schedule if needed
5. Celebrate your progress!

EXAMPLE WEEK (Monday-Sunday)

MONDAY
7:00-7:30 AM: 🔵 Dan Sfera (commute)
12:00-12:20 PM: 🟢 Read CFR (lunch)
8:00-8:30 PM: 🟡 Practice questions

TUESDAY  
7:00-7:30 AM: 🔵 Dan Sfera (commute)
8:00-8:30 PM: 🟢 Continue reading

WEDNESDAY
12:00-12:30 PM: 🟣 Review notes (lunch)
7:00-7:45 PM: 🔴 LIVE CLASS
8:00-8:30 PM: ⚪ Buffer

THURSDAY
7:00-7:30 AM: 🔵 Dan Sfera (commute)
7:30-8:00 PM: 🔴 OFFICE HOURS

FRIDAY
7:00-7:30 AM: 🔵 Dan Sfera (commute)
12:00-12:20 PM: 🟡 Quick practice quiz

SATURDAY
9:00-11:00 AM: 🟢 Deep reading session
2:00-3:00 PM: 🟣 Review week, make notes

SUNDAY
10:00-11:30 AM: 🟡 Weekly quiz + review
7:00-7:30 PM: 🟣 Weekly review ritual

TOTAL: ~7 hours study time + 1.25 hours live sessions = 8.25 hours

SUBMISSION

Submit your completed 12-week calendar showing:

• ✓ All 12 weeks mapped out
• ✓ Study time blocked for each week
• ✓ Live sessions and office hours included
• ✓ Color-coding or clear organization
• ✓ Buffer time built in
• ✓ Weekly review ritual scheduled

Formats accepted: Digital calendar screenshot, Excel/Google Sheets, hand-drawn/scanned, photo of planner

🎧 ASSIGNMENT 5: Listen to/Read Books (Horse Named Jim/Comprehensive Guide)

Purpose

Dan Sfera's audiobook provides comprehensive coverage of CCRP content.

Time Commitment

⏱️ 2-3 hours (listening + note-taking)

LISTENING GUIDE

ACTIVE LISTENING TECHNIQUES:

Before listening:

• Have notepad/digital notes ready
• Minimize distractions
• Set intention: "I'm learning about..."

During listening:

• Pause and replay confusing sections
• Note timestamps of important concepts
• Write down unfamiliar terms to look up
• Make connections to your experience

After each chapter:

• Summarize in 3-5 sentences
• List 3 key takeaways
• Note 2 questions for further exploration

CHAPTER NOTES TEMPLATE

Main Topic: _______________

Key Concepts:

Terms to Define:

Connections to My Experience/Course Content

Questions for Office Hours:

Summary (3-5 sentences):

SUBMISSION

Submit your notes from both chapters including:

• Key concepts from each chapter
• Terms you looked up
• Personal reflections/connections
• Questions that arose

💭 ASSIGNMENT 6: Reflection Worksheet - "Applying SOCRA Mindset to My Work"

Purpose

Connect the SOCRA Mindset framework to your real-world experience, making abstract concepts concrete and memorable.

Time Commitment

⏱️ 30-45 minutes

PART 1: The Four Pillars in Your Work

For each pillar, provide a specific example from your current or past research experience:

1. Regulatory Compliance FIRST

Describe a situation from your work where regulatory compliance was critical:

What would have happened if compliance hadn't been prioritized?

How does understanding CFR requirements change your perspective on this situation?

2. Participant Safety ALWAYS

Describe a decision you made (or saw made) that prioritized participant safety:

What was the potential risk, and how was it mitigated?

How would the SOCRA Mindset apply to this situation?

3. Data Integrity CONSTANTLY

Describe a data quality issue you've encountered (or prevented):

What systems/processes ensured data integrity?

How does 21 CFR Part 11 relate to this situation?

4. Documentation THOROUGHLY

Describe something that required meticulous documentation:

Why was thorough documentation important for this activity?

What documentation standards did you follow (or should have followed)?

PART 2: Bridging Implementation Science and IND Research

Reflect on these questions:

1. What aspects of implementation science/health services research translate directly to IND trials?

Examples: Research design, data collection, ethical considerations

Your answer: _______________

2. What gaps do you recognize in your current knowledge about IND/IDE research?

Be specific—these become your learning priorities.

Your answer: _______________

3. How can you use your implementation science strengths as assets in learning clinical research regulations?

Example: "My experience with REDCap will help me understand EDC systems"

Your answer: _______________

PART 3: Personal Learning Goals

1. By the end of this 12-week course, I want to feel confident about:

2. Topics I'm most nervous about:

3. My learning style preferences (check all that apply):

• Visual (diagrams, charts, reading)
• Auditory (lectures, discussions, audiobooks)
• Kinesthetic (hands-on, practice questions, teaching others)
• Reading/Writing (note-taking, summarizing, writing)

4. How I'll use my learning preferences to my advantage:

5. One commitment I'm making to myself for this certification journey:

📅 LOOKING AHEAD: Week 2 Preview

Next week we'll dive deep into:

• Informed consent elements in detail
• Special populations and consent considerations
• ICH GCP sections on informed consent
• Real-world consent scenarios and challenges

Come prepared with:

• Your 21 CFR Part 50 notes
• Questions about consent requirements
• Examples from your own work
• Baseline quiz results reviewed