TN-CTSI Certification Exam Preparation Course

Session 1

Session 2

Session 3

Session 4

Session 5
Session 6
Session 7
Session 8

Session 9
Session 10

Session 11
Session 12

Session 13
Session 14

Session 15
Session 16

Session 17

Session 18

Session 1: Historical Events/Evolution of Regulations and Human Subject Protections

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Session 2: Ethics/Research Misconduct

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Session 3: Regulations and Guidance

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Session Four: ICH GCP

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Session 5: IRB/IEC

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Session 6: Roles and Responsibilities

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Session 7: Study Start-up Part One

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Session 8: Study Start-up Part Two

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Session 9: Essential Documents/Documentation, Part 1

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Session 10: Essential Documents/Documentation, Part 2

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Session 11: Investigational Product

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Session 12: 21 CFR 312; 21 CFR 812; CFR 814

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Session 13: Recruitment, HIPAA Regulations in Clinical Research, 21 CFR 11

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Session 14: Safety and Compliance Reporting

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Session 15: Informed Consent, Part One

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Session 16: Informed Consent, Part Two

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Session 17: Monitoring/Auditing/Inspections

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Session 18: Contracts and Agreements; Study Closure; Differences between FDA, OHRP and ICH

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TN-CTSI Certification Exam Preparation Course Study Guide