REMEDIATION RESOURCES

For Students Struggling with Sponsor vs. Investigator Distinctions

Resource 1: Responsibility Matrix (Visual Aid #3 from Week 4 materials)

• Laminate and post at desk during study sessions
• Use as reference while completing homework
• Practice assigning responsibilities to random scenarios

Resource 2: Case Studies with Role-Play

• Assign "sponsor role" and "investigator role"
• Present scenario: "Adverse event occurred"
• Each person describes their actions and responsibilities
• Discuss what was missed or unclear

Resource 3: Simplified One-Page Comparison**

For Students Struggling with Safety Reporting Timelines

Resource 1: Timeline Calculator Tool (interactive or spreadsheet)

• Build confidence by entering data and seeing outputs
• Use for homework scenarios
• Create personal library of worked examples

Resource 2: Flashcard Deck (Section D: 16 cards)

• Review one card daily
• Cover answer first, then reveal
• Flag difficult cards

Resource 3: "Severity vs. Seriousness" Worksheet**

Practice distinguishing:

• Severe but not serious (e.g., severe headache that resolves)
• Serious but not severe (e.g., mild shoulder dislocation requiring surgery)
• Both severe and serious (e.g., anaphylaxis)

For Students Struggling with IND Application Requirements

Resource 1: Component Checklist (Visual Aid #1)

• Laminate and use while reading regulations
• Check off each component as you study it

Resource 2: Order-the-Components Exercise**

• Print components on index cards (shuffled)
• Practice arranging in correct order per 312.23
• Do this 3-5 times until automatic

Resource 3: Phase 1 vs. Phase 2/3 Comparison Table**

General Remediation Strategy

If struggling with a topic:

1. Reread the specific CFR section (not the summary)
2. Work through examples with that concept
3. Create your own scenario and apply the concept
4. Explain to someone else (verbally)
5. Do homework exercises related to that concept again