Week 1 Overview

Table of Contents

  1. Week 1 - Foundation Building
  2. 📋 TABLE OF CONTENTS
  3. 1️⃣ PERSONAL STUDY SCHEDULE TEMPLATE
  4. 2️⃣ WEEKLY PROGRESS TRACKER
  5. 3️⃣ REGULATION READING NOTES TEMPLATE
  6. 4️⃣ PRACTICE QUESTION LOG
  7. 5️⃣ CONCEPT FLASHCARD TEMPLATE
  8. 6️⃣ STUDY SESSION PLANNER
  9. 7️⃣ EXAM READINESS SELF-ASSESSMENT
  10. 8️⃣ RESOURCE QUICK REFERENCE SHEET
  11. 📊 12-WEEK MILESTONE TRACKER
  12. 💭 REFLECTION & MINDSET JOURNAL
  13. 🎯 GOAL SETTING WORKSHEET
  14. 📝 NOTES & ADDITIONAL RESOURCES

Week 1 - Foundation Building

Student Name: ___________________________
Start Date: ___________________________
Target Exam Date: ___________________________

📋 TABLE OF CONTENTS

  1. Personal Study Schedule Template
  2. Weekly Progress Tracker
  3. Regulation Reading Notes Template
  4. Practice Question Log
  5. Concept Flashcard Template
  6. Study Session Planner
  7. Exam Readiness Self-Assessment
  8. Resource Quick Reference Sheet

1️⃣ PERSONAL STUDY SCHEDULE TEMPLATE

My Weekly Availability Analysis

Fixed Commitments (Block these out first):

Day Work Hours Commute Family Time Sleep Other
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

Available Study Time (Identify pockets of time):

Time Block Monday Tuesday Wednesday Thursday Friday Saturday Sunday
6:00-7:00 AM
7:00-8:00 AM
12:00-1:00 PM
5:00-6:00 PM
6:00-7:00 PM
7:00-8:00 PM
8:00-9:00 PM
9:00-10:00 PM

Color Code:
🔴 Not Available | 🟡 Maybe Available | 🟢 Definitely Available

My Ideal Weekly Study Plan

Goal: 5-7 hours per week (not including live sessions)

Activity When Duration Notes
Live Class 45 min Fixed
Office Hours 30 min Fixed
Reading (CFRs) ___ hours
Audio (Sfera) ___ hours
Practice Questions ___ hours
Review/Notes ___ hours
TOTAL ___ hours

My Study Rituals:

2️⃣ WEEKLY PROGRESS TRACKER

Week 1 Progress

Homework Checklist:

Time Tracking:

Day Activity Time Spent Completed?
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
TOTAL ___ hours

Weekly Reflection:

  1. What went well this week?

  2. What was challenging?

  3. What will I adjust for next week?

  4. Questions I have:

Confidence Rating (1-5): ⭐⭐⭐⭐⭐

3️⃣ REGULATION READING NOTES TEMPLATE

21 CFR Part 50 Reading Notes

Date: _______________
Section Read: _______________
Time Spent: _______________

Before Reading:

During Reading:

Section Key Concept In My Own Words Example from My Work Questions

Key Definitions (Write them here):

  1. _______________: _______________________________________________
  2. _______________: _______________________________________________
  3. _______________: _______________________________________________

The BIG Ideas (Max 3 per section):

After Reading:

Testable Content (What seems exam-likely?):

21 CFR Part 50: Quick Reference Sheet

Purpose of Part 50: _______________________________________________

The 8 Basic Elements of Informed Consent:

# Element What it Means Example
1
2
3
4
5
6
7
8

Additional Elements (when applicable):

Exceptions to Informed Consent:

4️⃣ PRACTICE QUESTION LOG

Question-by-Question Analysis

Date: _______________

Q# Domain Got Right? If Wrong: Why? Concept to Review Priority
1 ✓ / ✗ H/M/L
2 ✓ / ✗ H/M/L
3 ✓ / ✗ H/M/L
4 ✓ / ✗ H/M/L
5 ✓ / ✗ H/M/L

Common Reasons I Got Questions Wrong:

Patterns I Notice:

Action Items:

Weekly Quiz Summary

Week: _______________
Quiz Title: _______________
Score: % (/_____ correct)

By Domain:

Compared to Last Week:

Concepts Mastered This Week: ✅

Concepts Still Struggling With: ⚠️

5️⃣ CONCEPT FLASHCARD TEMPLATE

Print, cut out, and use for spaced repetition study

FLASHCARD #1

FRONT: What are the 8 basic elements of informed consent required by 21 CFR 50.25(a)?

BACK:

  1. Statement that research is involved
  2. Purpose of research
  3. Risks and discomforts
  4. Benefits (or lack thereof)
  5. Alternative procedures/treatments
  6. Confidentiality protections
  7. Compensation and treatment for injury
  8. Voluntary participation & right to withdraw

Source: 21 CFR 50.25(a)

FLASHCARD #2

FRONT: What does the acronym "IRB" stand for and what is its primary purpose?

BACK: IRB = Institutional Review Board

Purpose: Independent committee that reviews and approves research to protect the rights, safety, and welfare of human research participants.

Key Requirement: Must review research at least annually.

Source: 21 CFR Part 56

FLASHCARD #3

FRONT: Define "Serious Adverse Event" (SAE) and list the criteria.

BACK: SAE: An adverse event that results in any of the following:

  1. Death
  2. Life-threatening event
  3. Inpatient hospitalization or prolongation
  4. Persistent or significant disability/incapacity
  5. Congenital anomaly/birth defect
  6. Important medical event requiring intervention

Source: 21 CFR 312.32, ICH E6

FLASHCARD TEMPLATE (Blank - Create Your Own)

FRONT:

[Write your question here]

BACK:

[Write the answer here]

Source: [Cite the regulation or document]

Instructions for Flashcard Use:

  1. Create 5-10 cards per study session
  2. Review daily using spaced repetition
  3. Sort into piles: "Know Well," "Getting There," "Need Review"
  4. Focus most time on "Need Review" pile
  5. Remove cards from rotation once mastered

6️⃣ STUDY SESSION PLANNER

Individual Study Session Plan

Date: _______________
Start Time: _______________
End Time: _______________
Duration: _______________

Today's Goals:

Materials Needed:

Study Plan:

Time Activity Materials Done?
[ ]
[ ]
[ ]
Break (10 min)
[ ]
[ ]
[ ]

Session Reflection:

Energy Level: (1-5) ⭐⭐⭐⭐⭐
Focus Level: (1-5) ⭐⭐⭐⭐⭐
Confidence Level: (1-5) ⭐⭐⭐⭐⭐

7️⃣ EXAM READINESS SELF-ASSESSMENT

Monthly Progress Check

Month: _______________
Weeks Completed: _______________
Weeks Remaining: _______________

Knowledge Assessment (Rate 1-5):

Concept Area Week 1 Week 4 Week 8 Week 12
Regulatory Framework (CFRs, ICH)
Informed Consent Requirements
IRB/IEC Requirements
IND/IDE Processes
Study Conduct & Monitoring
Adverse Event Reporting
Data Integrity & Documentation
Study Closeout Procedures

Scale: 1=No knowledge, 2=Basic awareness, 3=Moderate understanding, 4=Strong understanding, 5=Mastery

Practice Quiz Scores:

Week Quiz Score Improvement
Baseline _____% -
Week 2 _____% +/- _____%
Week 4 _____% +/- _____%
Week 6 _____% +/- _____%
Week 8 _____% +/- _____%
Week 10 _____% +/- _____%
Week 12 _____% +/- _____%

Goal Trajectory:

Am I on track? YES / NO / ALMOST

If not on track, what adjustments are needed?

Exam Day Readiness Checklist

4 Weeks Before:

2 Weeks Before:

1 Week Before:

Day Before:

Exam Morning:

8️⃣ RESOURCE QUICK REFERENCE SHEET

Regulations Quick Access

Regulation What it Covers Where to Find It
21 CFR Part 11 Electronic Records www.ecfr.gov → Title 21 → Part 11
21 CFR Part 50 Informed Consent www.ecfr.gov → Title 21 → Part 50
21 CFR Part 56 IRBs www.ecfr.gov → Title 21 → Part 56
21 CFR Part 312 INDs www.ecfr.gov → Title 21 → Part 312
ICH E6(R2) Good Clinical Practice www.fda.gov → search "ICH E6"

Key Websites Bookmarked

Emergency Contacts

My Study Toolkit Inventory

Physical Materials:

Digital Tools:

Environmental Setup:

📊 12-WEEK MILESTONE TRACKER

The Big Picture

Week Theme Key Topics Status Notes
1 Foundation Exam structure, SOCRA Mindset, Resources [ ]
2 Informed Consent 21 CFR 50, ICH E6 consent sections [ ]
3 IRB/Ethics 21 CFR 56, IRB processes [ ]
4 IND Basics 21 CFR 312, sponsor responsibilities [ ]
5 Study Conduct Enrollment, screening, visits [ ]
6 Safety Reporting AEs, SAEs, reporting timelines [ ]
7 Monitoring & QA SDV, CAPAs, audits [ ]
8 Data Management 21 CFR 11, audit trails, queries [ ]
9 IP Management Accountability, storage, dispensing [ ]
10 Integration Complex scenarios, case studies [ ]
11 Mock Exams Full-length practice tests [ ]
12 Final Prep Review, confidence building [ ]

Visual Progress Bar:

Week: [1][2][3][4][5][6][7][8][9][10][11][12]
Done: [✓][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ][ ]

💭 REFLECTION & MINDSET JOURNAL

Week 1 Reflection

My "Why" for Pursuing SOCRA Certification:

My Biggest Fears:

How I'll Address These Fears:

My Strengths:

How I'll Leverage My Strengths:

My Support System:

My Commitment to Myself: I, _________________, commit to dedicating 12 weeks to preparing for SOCRA certification. I will:

Signature: _______________ Date: _______________

Weekly Affirmations (Read daily!)

✨ "I am capable of learning clinical research regulations."

✨ "Each day, I am building competency."

✨ "Struggling is part of learning, not a sign of failure."

✨ "I have the resources and support I need."

✨ "Progress, not perfection, is my goal."

✨ "I will pass the SOCRA exam."

🎯 GOAL SETTING WORKSHEET

SMART Goals for SOCRA Preparation

Long-Term Goal (12 weeks):

Month 1 Goal (Weeks 1-4):

Month 2 Goal (Weeks 5-8):

Month 3 Goal (Weeks 9-12):

Weekly Sub-Goals:

Week Goal Achieved?
1 [ ]
2 [ ]
3 [ ]
4 [ ]

Reward System:

📝 NOTES & ADDITIONAL RESOURCES

Use this space for additional notes, observations, or resources you discover

End of Week 1 Student Workbook

Print this workbook and keep it with your study materials throughout the 12-week course. Update it regularly to track your progress and maintain motivation!

Remember: You've got this! One week at a time, one concept at a time, one question at a time. 💪🎓