Curriculum
This program features blended learning comprising of a two-day workshop (face to face or virtual) and 4 weeks of eLearning.
Over the course of five weeks, participants participate in the following topics:
Introduction to Good Clinical Practice
- Introduction to Good Clinical Practice
- Roles and Responsibilities
- Research and discovery stage and drug development
- Regulatory submission and lifecycle concept
Resources
Video: International Conference on Harmonisation & GCP
Presentation: Good Clinical Practice Presentation Henry Silverman
Website: Introduction to Good Clinical Practice Global Health Training Centre
Activities
Lesson: Introduction to ICH
Trial Management I
- Selecting and Initiating Study Sites
- Study Protocol, Essential Documents,
- PreStudy and Essential Documents
Resources
Video: Key Players in Clinical Trials
Video: Initiation Visit
Video: Source Documents and CRFs
Video: Study Visits
Trial Management II
- Protocol Non-adherences
- Quality control and assurances
- Monitoring and closing clinical trials
Resources
Video: Quality Control & Assurance
Presentation: Quality Monitoring and Quality Assurance
Video: Protocol NonAdherence
Subject Management I: Recruitment and Informed Consent
- Recruitment and Screening
- Retention
- Informed Consent
Resources
SCORM: Informed Consent
Presentation: Screening and Informed Consent
URL: The Process of Informed Consent
Subject Management II: Clinical Trial Safety
- Participant Safety
- Adverse Event Reporting
- Incidental Findings
- Data Safety Monitoring and Data Safety Monitoring Boards
Resources
Video: Safety in Clinical Trials AEs and DSMBs
Presentation: Monitoring Clinical Trials
Presentation: Adverse Events Tamer Hifnawy
Activities
Lesson: Monitoring for Safety
End of Course Activities
Post-test
Print Your Course Certificate