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Certification Exam Prep Course

A series to prepare clinical researchers for the SOCRA CCRP (Certified Clinical Research Professional) or the ACRP CCRC (Certified Clinical Research Coordinator) certification exam. This course also serves as an orientation for anyone interested in learning about clinical research.

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Historical Events, Evolution of Regulations, ​
and Phases and Types of Studies

Session 1 PPT

Ethics and Research Misconduct​

Session 2 PPT

Regulations and Guidance​

Session 3 PPT

ICH GCP​

Session 4 PPT

Institutional Review Board and Institutional Ethics Committee​

Session 5 PPT

Roles and Responsibilities​

Session 6 PPT

Study Startup, Part I​

Session 7 PPT

Study Startup, Part 2​

Session 8 PPT

Essential Documents, Part I​

Session 9 PPT

Essential Documents: Part 2​

Session 10 PPT

Investigational Product

Session 11 PPT

21 CFR 312, 21 CFR 812, 21 CFR 814

Session 12 PPT

Recruitment | HIPAA Regulations in Clinical Research | 21 CFR 11​

Session 13 PPT

Safety and Compliance Reporting​

Session 14 PPT

Informed Consent, Part 1​

Session 15 PPT

Informed Consent, Part 2

Session 16 PPT

Monitoring and Auditing​

Session 17 PPT

Contracts, Study Closure, Differences Between FDA OHRP and ICH​

Session 18 PPT