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GCP Course

CREDE Refresher GCP Course


Description
Refresher Course in Good Clinical Practice (GCP)
Content
  • Section 1: Introduction
  • Welcome
  • Welcome and Introduction
  • Content introduction
  • Section 2:History and Guidelines
  • History & Guidelines Intro
  • History: some key incidents and guidelines
  • The Nuremberg Code
  • Thalodomide and Declaration of Helsinki
  • Risk vs benefit
  • Declaration of Helsinki: controversies and case scenarios (Advanced)
  • Declaration Helsinki extra reading
  • Ethical use of unethical data (Advanced)
  • Tuskegee and Belmont report
  • Belmont Report
  • Section test: history and guidelines
  • Section 3: ICH and SA GCP
  • Intro GCP
  • Download GCP guidelines
  • GCP Definition
  • ICH GCP
  • ICH GCP R2 updates
  • SA GCP 2020
  • New 2020 SA GCP revision
  • Updated section SA GCP 2020
  • Principles of GCP
  • subject vs participant (Advanced)
  • Case scenario: justice (Advanced)
  • GCP test
  • Section 4: The Clinical Development Pathway and Phases of Clinical Trials
  • Phases of Clinical Trials
  • Phases: video
  • Phases Recap
  • Phases Test
  • Section 5: Approval of research studies
  • Approvals
  • Case scenario approvals 1
  • Case scenario approvals 2
  • Clinical Trial Registries (Advanced)
  • Ethics Committees
  • SAHPRA
  • Approvals & REC test
  • Section 6: Investigator Responsibilities
  • Investigator responsibility intro
  • Role of the Investigator
  • PI, sub PI terminology
  • C0-PI
  • Responsibilities of the investigator
  • Investigator responsibility (movie)
  • Multi site studies (Advanced)
  • Delegation & Supervision: lessons from Disney (Advanced)
  • Delegation & supervision definition
  • Importance of Delegation & Supervision
  • Evidence of Delegation & Supervision
  • Education, Training & Experience
  • Test: Investigator responsibilities
  • Section 7: Informed Consent
  • Informed Consent Intro
  • 5 elements of Informed Consent
  • Informed Consent: Information
  • Informed Consent: Understanding
  • Informed Consent: competency
  • Informed Consent: minors
  • Informed Consent: case scenarios
  • Informed Consent: case scenario 2
  • Informed Consent: process and documentation
  • Informed Consent: illiterate participant
  • Informed Consent: coercion vs undue influence
  • Informed Consent: reimbursements
  • Vulnerability
  • Informed Consent vid
  • Informed Consent test
  • Section 8: Monitoring, auditing and inspections
  • Monitoring, Auditing and Inspections
  • Roles in monitoring and auditing
  • Auditor vs monitor vs inspector
  • More on monitoring (Advanced)
  • Test: monitoring, auditing, inspections
  • Section 9: Investigational Product
  • Investigational Product
  • Section 10: Data Management and Good Documentation Practice
  • Data Management Introduction
  • Flow of Data
  • Data : plural or single?
  • Essential Documents
  • Importance of source documentation
  • ALCOAC
  • Good Documentation Practice: some examples
  • electonic signature
  • Compliance clip
  • IP and GDP test
  • Section 11: Safety Issues
  • Participant Safety in Clinical Trials
  • Safety Responsibilities
  • Adverse Event (AE)
  • Aspects of Adverse Events (Advanced)
  • AE clip
  • Serious Adverse Event (SAE)
  • Safety test
  • Section 12: Conclusion, Reflections and Certification
  • Conclusion 1
  • Conclusion 2
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: 3 years